Salter Labs and Westmed are now part of the SunMed family of brands.

Join Our Team

Career Opportunities with SunMed:

The Marketing Communications Specialist will provide graphic design and project management support to SunMed’s Marketing Communications team. Graphic design, file management, Photoshopping, photography, and experience with a variety of creative platforms is critical. This individual will possess excellent verbal and written communication skills, be highly organized, be hyper-focused on team coordination and deadlines, and be flexible to meet the evolving needs of our organization. Candidate must be comfortable with coordinating trade shows including designing of booth, pre-show planning, management of attendees and supplies, and post-show reporting.

Knowledge:

Acquired through education, certifications, training, experience.

Skills and Abilities:

The candidate will be exemplary in InDesign, Illustrator, and Photoshop. Strong MS Office and project management platform experience preferred. Print production, trade show, website maintenance, and social media experience is a plus. Strong understanding of English language.

Level of Experience:

3-5 years in graphic design and marketing coordination.

Level of Education:

Bachelor’s degree in Graphic Design or related; or comparable experience.

Travel:

Minimal for trade show support or national SunMed meetings.

Essential Duties and Responsibilities:

Provide creative support for:

·       Marketing material production

·       Catalog design

·       Internal communication initiatives

·       Website content and assets

·       Photography and inventory control of image library

Trade show support:

·       Design of trade show booth and equipment

·       Registration and pre-show preparation

·       Coordination of shipping

·       Management and communication to attendees

·       Tradeshow material inventory management

·       Post-show surveying

Additional support:

·       Management of asset inventory – files and photography

·       Maintains and drives project plans, keeping team on track

·       Internal office design support – Ops, HR, Quality, etc.

Quality Policy:

SunMed is committed to excellence and the highest level of customer satisfaction for all products and processes. We are committed to the delivery and support of safe and effective anesthesia, respiratory and urology devices through:

Excellence

We are dedicated to providing the quality of excellence through teamwork, leadership, open communication and continuous improvement to achieve the company’s objectives and meet our customer’s expectations.

Continuously improve the effectiveness of our Quality Management System that delivers compliant and sustainable products, processes and systems.

Customers

We will adapt to customers changing needs at all times in an environment of continuous improvement of high quality products and services.

Products

We distribute products that are safe, reliable and in compliance with applicable US and International regulatory requirements, standards and regulations.

Catalog Inside sales representative will identify, nurture and turn leads into customers. Will work within an assigned territory to generate, reactivate, and maintain customers.

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.

Skills & Abilities:

· Very strong organizational skills

· Perform all tasks and follow-up with a sense of urgency

· Proficient in Excel, Word, PowerPoint

· Strong verbal, written and interpersonal skills

· Ability to work collaboratively with colleagues and staff to create results driven, team-oriented environment

· Analytical skills are paramount

Level of Experience:

1-3 years

Level of Education:

Bachelor’s Degree preferred

Travel: Amount of travel availability required for position.

None

Essential Duties and Responsibilities

  • The core tasks, duties, and responsibilities that must be performed on the job.
  • Inside Sales Representative will pursue, create, manage, and nurture sales leads within an assigned territory or list of customer accounts.
  • Maintain positive ongoing relationships with customers, assessing customer needs and suggesting appropriate products.
  • Has a clear understanding of our product line and will source new sales opportunities through inbound lead follow-up and outbound cold calls and emails.
  • Researching accounts, identify key players and track all activity through a CRM or pipeline.
  • Provides data analysis by inspecting, cleansing, and modeling information to support sales decision making.
  • Provides support to marketing managers in the development and sales support of one or more marketing segments.
  • Helps to coordinate and develop marketing tools, assists with trade shows, literature development, presentations, and publicity.
  • Collect, analyze, and maintain an up-to-date library of competitive product information.
  • Provide input on new product development.
  • Provide sales training on assigned products, as required.
  • Participate in the pursuit of new business opportunities and new markets, as necessary.
  • Coordinate orders with customer service.
  • Provide unparalleled sales support by answering questions/resolving account manager/customer questions.
  • Accountable for all record keeping as appropriate and in accordance with company specifications.
  • Other general and specified duties may be assigned, consistent with the company’s goals, objectives and interests.

Other Responsibilities

♦ Focus on achieving our Company mission

♦ Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.

♦ Inspire the trust of others; treat people with respect and dignity, and embrace the value of diversity.

♦ Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.

♦ Contribute to building and maintaining a positive team environment.

♦ Assure all policies and guidelines are implemented and followed

This position is located in Tucson AZ.

Position Summary
This position is responsible for managing improvement projects, identifying, and eliminating manufacturing variances, and process improvement in injection molding, extrusion, blow molding and dipping. Success will be defined and measured through optimization of manufacturing processes, line layouts and machine optimization for cost savings and increased throughput.

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, .skills, abilities, level ofeducation, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.

The ideal candidate for this position will have knowledge of process qualification and validation used in the manufacture of medical devices. Experience with manufacturing processes for plastic components such as injection molding knowledge is preferable.

Skills & Abilities:

The ideal candidate will have the ability to work with mathematical concepts and apply those concepts to practical situations. Proficiency with standard computer software and knowledge of CAD software is required. Specific experience with Solid works is desired.

Level of Experience:

3+ years of experience in an engineering position. Experience in a medical device, pharmaceutical, or plastics manufacturing facility is a plus.

Level of Education:

The position requires the candidate to at least have a bachelor's degree in manufacturing, industrial, or mechanical engineering.

Travel: The amount of time required for this position will depend on specific project requirements.

Essential Duties and Responsibilities

  • The core tasks, duties, and responsibilities that must be performed on the job.
  • Develop and improve molding processes for new and existing products.
  • Develop validation protocols for IQ, OQ and PQ, work instructions, cell layouts, etc.
  • Execute IQ + OQ + PQ for new or existing molded components, collect data for PQ reports.
  • Complete PQ reports to transfer products into ongoing production or make improvements to existing processes
  • Provide daily production support to the Molding and assembly operations and assist Extrusion and Blow Molding operations.
  • Assist with development, implementation, continuous improvement of quality procedures, SOP's, Ol's, and other manufacturing related documentation.
  • Coordinate, prepare, and test products for the preparation of Device Master Records (DMR's).
  • Review, modify, and approve validation documents per FDA guidelines.
  • Create and modify existing product specifications based on ISO standards, and customer requirements.
  • Oversee product improvement projects and manage project timelines.
  • Perform/coordinate engineering product prototyping and testing.
  • Manage projects including resource allocation.
  • Train associates with work techniques, and skills required to perform product assembly or processing.
  • Assist in maintaining Food & Drug Administration (FDA), Good Manufacturing Practices (GMP), and ISO Compliance.
  • Other Responsibilities Focus on achieving our Company mission
  • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
  • Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
  • Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
  • Contribute to building and maintaining a positive team environment.
  • Assure all policies and guidelines are implemented and followed.

Quality Policy:

At SunMed, quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

Excellence

• We are dedicated to providing the quality of excellence through teamwork, leadership, open communication and continuous improvement to achieve the company's objectives and meet our customer's expectations.

Continuously improve the effectiveness of our Quality Management System that delivers compliant and sustainable products, processes and systems.

Customers

+ We will adapt to customers changing needs at all times in an environment of continuous improvement of high quality products and services.

Products

We distribute products that are safe, reliable and in compliance with applicable US and International regulatory requirements, standards and regulations.

Leads monthly analysis of Income Statement, Balance Sheet and Cash Flow Statement.  Prepares Monthly financial results package for business leadership, bank requirements and other constituents. Collaborates with finance leadership team and across functions, as a key business resource and financial partner.

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance.  These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience. Skills required include financial statement acumen, financial statement analysis, and accounting close process knowledge.

Level of Experience:

5-7 Years of accounting and financial management experience

Level of Education:

Bachelor’s degree in accounting or finance required

Travel: Minimal

Essential Duties and Responsibilities

The core tasks, duties, and responsibilities that must be performed on the job.

  • Prepares, analyzes and summarizes key financial information, trends, ratios and other metrics on a monthly and quarterly basis.
  • Provides weekly income statement analysis to company leadership and assesses any unusual adjustments or transactions.
  • Works with the leaders of the business to analyze variances in their department cost centers and leads the annual departmental budget process.
  • Participates in the monthly, quarterly and annual financial close process
  • Prepares the monthly financial statement package, reviewed by company leadership and disbursed to key constituents including the bank and investors.
  • Supports the annual audit process.
  • Manages the company’s cash through analysis of Accounts Receivable, Accounts Payable and the overall cash cycle.
  • Analyzes the balance sheet account reconciliations and provides oversight to Intercompany transactions
  • Participates in integration and accounting for newly acquired businesses.
  • Identifies and implements process improvements to enhance efficiency and controls.
  • Manages, trains and develops financial analyst.
  • Maintains professional and technical knowledge.
  • Contributes to overall business performance through supporting ad hoc financial analysis across functions

Other Responsibilities

  • Focus on achieving our Company’s vision and goals
  • Inspire the trust of others
  • Contribute to building and maintaining a positive team environment.

Quality Policy

At SunMed, Quality is our promise.  It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

This position is located in Tucson AZ.

The Document Control Manager is responsible for overall Quality Management Systems compliance with FDA Quality System Requirements, ISO 13485 standard and other applicable requirements.  This position implements, maintains, and improves systems to ensure product meets defined quality requirements and customer satisfaction is met. 

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance.  These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.

  • Knowledge of quality standards for medical devices (e.g. ISO 13485, FDA QSR, EU Medical Directives, and Canadian Medical Device Regulations.

Skills and Abilities:

  • Excellent verbal and written communication skills. Bilingual is required (English/Spanish).
  • Excellent organization skills and attention to detail. 
  • Ability to multi-task.
  • Sound, systematic problem solving skills.
  • Strong computer skills: MS Word, MS Excel (charting), PowerPoint, Database Management and Statistical Analysis.

Level of Experience:

  • A minimum of 4 years of Quality System experience in an FDA regulated and/or ISO certified facility (preferably ISO 13485).

Level of Education:

  • Bachelor/Associate degree or equivalent work experience.

Travel:

Occasional overnight travel (up to 25%). Must be able to travel once a month for a week if required

Quality Engineering Manager will ensure the overall quality of a finished-good product that is designed and/or manufactured internally or thru the approved supply chain.   This position ensures that projects and products are capable and will meet specified standards and customer requirements.  As a Quality Manager, you will be involved in a both short design change efforts and longer-term new product development projects. Regular use of problem-solving tools and statistical analysis to support design verification & validation, definition of acceptance criteria, risk assessments, and investigation.  As a leader within the Quality department, this position will participate in strategic initiatives including integration of acquisitions, manufacturing transfers, and continuous improvement activities. Position will lead a cross functional team and is expected to drive a strong focus on team development, engagement, and professional growth.  

Essential Duties and Responsibilities

The core tasks, duties, and responsibilities that must be performed on the job.

  • Ensures customer receives excellent service with quality concerns through timely responses and products.
  • Represents customer requirements internally.
  • Communicates with outside departments within the plant and in other company facilities to ensure a continuous operational flow. Communicates with customers concerning quality and testing issues.
  • Lead a team of 5-10 engineers and quality specialists focused on product quality.  
  • Investigates operational and technical issues, leading root cause and troubleshooting activities, resolution of problems, and thoroughly documented activities.
  • Maintain SOP's and quality control documents for product and manufacturing.
  • Utilizes data to drive quality control results.
  • Reports to upper management on the performance of product quality and any need for improvement
  • Responsibility to own, review and approve documentation: change control, validation protocols and reports, test reports, nonconforming dispositions, CAPAs and customer complaints.
  • Support pre-audit and post audit activities and facilitate closure of audit findings.
  • Create, identify, and report on quality metrics weekly and monthly.
  • Identify areas of opportunity and support continual improvement of the Quality Management System.

Other Responsibilities

  • Focus on achieving our Company mission.
  • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
  • Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
  • Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
  • Contribute to building and maintaining a positive team environment.
  • Assure all policies and guidelines are implemented and followed.

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance.  These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.

  • Knowledge of quality standards for medical devices (e.g., ISO 13485, FDA QSR, MDSAP, EU Medical Directives, and Canadian Medical Device Regulations.

Skills and Abilities:

  • Excellent verbal and written communication skills.
  • Excellent organization skills and attention to detail. 
  • Ability to multi-task.
  • Sound, systematic problem-solving skills.
  • Strong computer skills: MS Word, MS Excel, PowerPoint, Database Management and Statistical Analysis.

Level of Experience:

  • A minimum of 5 years of Quality System experience in an FDA regulated and/or ISO certified facility (preferably ISO 13485).
  • A minimum of 5 years in a leadership role, leading and mentoring employees

Level of Education:

  • Bachelor/Associate degree or equivalent work experience.

Travel:

  • Occasional overnight travel (up to 25%).

Quality Policy:

At SunMed, quality is our promise.

It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

 

This position is focused on quality within SunMed’s supply chain and supports Production, Incoming Inspection, Purchasing, Customers, Suppliers and Engineering. This function interprets, defines, and develops product quality requirements, working in collaboration with suppliers to ensure manufacturing processes are robust and capable. This position will drive change within both plant manufacturing and component suppliers to resolve component and finished device issues and will lead problem solving activities within internal and external organizations.  Additional responsibilities will include the development and presentation of supplier performance metrics and assurance of supplier standing under the SunMed quality management system.   

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

Essential Duties and Responsibilities

  • The core tasks, duties, and responsibilities that must be performed on the job.
  • Drives improvement and corrective action in the quality of components and finished goods sourced from outside suppliers.
  • Provide technical support in the selection of suppliers and manufacturing processes.
  • Monitor supplier performance to drive supplier corrective actions and manage supplier standings within the SunMed approved supplier list.
  • Initiate and manage Supplier Corrective Actions (SCARs)
  • Own the assessment and approval of suppliers, along with assurance of proper documentation, certifications, and assessment in alignment with SunMed procedures.
  • Conduct supplier audits for assurance of supplier quality system management.
  • Interpret spec and requirements for Production and Incoming Inspection and develop acceptance criteria.
  • Present to senior leadership on supplier performance at Monthly review and provide direction as required.  
  • Initiate continuous improvement projects for product quality using data analytics.
  • Collaborate with Sustainment Engineering, New Product Development, Sales, and Marketing on new opportunities and product improvements.
  • Support the management of the Quality System with process improvements.
  • Represent SunMed’s quality system in internal and external audits, as per ISO 13485.

Other Responsibilities

  •  Focus on achieving our Company mission
  • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
  • Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
  • Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
  • Contribute to building and maintaining a positive team environment.
  • Assure all policies and guidelines are implemented and followed.

Knowledge: Acquired through education, certifications, training, experience.

  • Understanding and experience in AQL inspection, control plans and interpretation of spec and drawings.
  • Basic understanding of mechanical engineering concepts.
  • Ability to analyze defective products.
  • Strong decision-making abilities.
  • Demonstrated technical writing skills.
  • Proven ability to work across organizational functions.
  • Strong ability to multi-task and to manage time.

Level of Experience:

  • 5+ years of experience in a quality or supplier quality role.
  • Exposure to the FDA, medical device or medical manufacturing.
  • Experience in continuous improvement is preferred.
  • Experience in quality systems and management.
  • Project Management experience

Level of Education:

Bachelor’s degree in engineering discipline

ASQ certification is a plus.

Travel:
International travel to China and Mexico is expected.       Approximately 20%.

Quality Policy:

At SunMed, quality is our promise.

It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

The Complaint Coordinator role will be responsible for supporting the review and handling of customer complaints, including the assurance of proper documentation, record of details, complaint trending, and management to closure.  Additionally, the coordinator will also manage the return of product and determination of disposition in collaboration with customer service, finance, and warehouse personnel.  

Essential Duties and Responsibilities

The core tasks, duties, and responsibilities that must be performed on the job.

 
  • Review the intake of all customer complaints for completion of details and accuracy of report.
  • Assign complaints appropriately to RA and Quality Engineering and manage timeliness of complaint closure to quality objectives and reporting guidelines.
  • Manage the complaint data inputs for monthly trending and continuous improvement management.
  • Global process owner for return management, providing guidance across all sites.
  • Lead the Returns process for the Grand Rapids site, to include quality determination for disposition and documentation of process through customer service warehouse, and inventory adjustment.
  • Complete all associated document control requirements.
  • Clearly communicate project status, timelines, and risks.

Other Responsibilities

  • Focus on achieving our Company mission
  • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
  • Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
  • Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
  • Contribute to building and maintaining a positive team environment.
  • Assure all policies and guidelines are implemented and followed.

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance.  These competencies are generally demonstrated through specific service, education, or training.

Knowledge:

  • Knowledge of quality standards for medical devices (e.g. ISO 13485, FDA QSR, EU Medical Device Directives, and Canadian Medical Device Regulations).

Skills and Abilities:

  • Customer Service Experience
  • Excellent verbal and written communication skills.
  • Excellent organization skills and attention to detail. 
  • Ability to multi-task.
  • Sound, systematic problem-solving skills.
  • Strong computer skills: MS Word, MS Excel, PowerPoint, and Database Management.

Level of Experience:

  • A minimum of 2-4 years of Quality System experience in an FDA regulated and/or ISO certified facility (preferably ISO 13485).

Level of Education:

  • Bachelor/Associate degree preferred.
  • Minimum:  High school degree plus equivalent work experience.

Travel:

  • Occasional overnight travel (up to 25%).

 

Quality Policy:

At SunMed, quality is our promise.

It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

 

 

POSITION SUMMARY:

These positions are responsible for handling/moving/documenting raw materials, finished goods, and in-bound freight in the warehouse.

ESSENTIAL DUTIES AND RESPONSIBILITIESFOR ALL POSITIONS:

  • Careful and safe operation of stand-up and sit-down forklifts/reach trucks
  • Loading and unloading materials on the dock
  • Prepare work order documents
  • Organize, stock, and rotate raw materials and finished goods
  • Inventory control
  • Maintaining cleanliness of warehouse such as sweeping, mopping, trash pickup, etc.
  • Preventative maintenance of warehouse equipment
  • Other duties as assigned

POSITION A:

  • Handling raw materials entering Molding Dept.
  • Handling Return to Stock materials from Assembly
  • All of Essential Duties and responsibilities listed above

POSITION B:

  • Primary focus is handling all raw materials exiting Molding Dept.
  • Pulling all raw materials for satellite plants
  • All of Essential Duties and responsibilities listed above

POSITION C:

  • Primary focus is handling all raw materials entering Assembly Dept.
  • Maintaining Kanban stocking racks
  • All of Essential Duties and responsibilities listed above

 

QUALIFICATION:

  • 1 year certifiable experience in operation of stand-up and sit-down forklifts/reach trucks/pallet jacks
  • High school education or equivalent
  • Basic math skills
  • Able to read, write, speak, and comprehend English
  • Organizational and communication skills
  • Demonstrated ability to follow instructions and work requirements with minimal supervision
  • Able to lift 50 lbs.
  • Detail oriented
  • Problem solving skills
  • Able to maintain a good working relationship with co-workers and the general public

LEVEL 1:             Trained and able to perform all functions of Position A or B

LEVEL 2:             Trained and able to perform all functions of Position A or B and one other position

LEVEL 3:             Trained and able to perform all functions of Positions A, B, & C

This role must work out of our Tucson AZ location

POSITION SUMMARY:

This position will coordinate domestic and international shipments with internal and external customers to ensure we provide safe and timely shipping and delivery of products as well as excellent customer service.   Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.  Must be able to work under pressure and meet deadlines while maintaining a positive attitude and providing excellent customer service to internal and external customers.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Prioritize, print daily picking tickets for distribution center.
  • Coordinate international shipments – working with distribution center to determine equipment needs, obtaining quotes, preparing packing lists, customs documents and reviewing letters of credit.
  • Negotiates transportation rates and/or services.
  • Meet with freight carriers semi-annually to discuss service level.
  • Assist in truck planning including establishing routes, determining rates, carrier assignment delivery times and finalizing carrier selections for loads.
  • Obtain truck quotes, including expedites, flatbeds, air freight and specialized equipment.
  • Respond to customer inquiries or complaints regarding Traffic related issues and determine best methods to resolve problems to ensure customer satisfaction.
  • Good written and verbal communication skills.
  • Timely decision making and good time management skills.
  • Conscientious with a focus on quality.

Qualifications

  • 3+ years’ experience in traffic and transportation. International experience is a definite plus. Must also have proficiency in Microsoft Office, be highly organized, able to prioritize, and work well in a team environment.
  • 3+ years’ of shipping, receiving, warehouse operation, inventory management and import/export operations experience.
  • Works well unsupervised
  • Mechanical aptitude
  • Superior customer facing skills
  • Strong administrative skills and experience
  • Proven track record of success and stability
  • Demonstrated solid decision making
  • Ability to provide new ideas – “think outside the box”
  • Must be willing to work extended hours and weekends as needed
  • Proficient using Microsoft Office programs

 

This is a general description of the kinds of duties and responsibilities that are performed by employees who have this title. It shall not be construed as an all-inclusive determination of the specific duties and responsibilities of any position. It is not intended in any way to limit the right of any manager or supervisor to assign, direct and control the work of employees under his/her supervision.

The International Regulatory Manager is responsible for establishing and sustaining the global device registrations and licenses for the organization.  This position will work closely with the International Sales team to service customer needs

The International Regulatory Manager will lead our efforts in compliance to global market requirements.  This position will identify and implement relevant guidance, standards, and requirements.  This includes, but is not limited to, MDSAP (Canada, Brazil, Australia, and Japan) and EU requirements.

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance.  These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.

  • Knowledge of quality standards and regulations for medical devices (e.g. ISO 13485, FDA QSR, MDSAP, EU Medical Device Directives, and EU Medical Device Regulations).

 Skills & Abilities:

  • Excellent technical writing skills.
  • Excellent verbal and written communication skills.
  • Excellent organizational skills and attention to detail.
  • Ability to multi-task.
  • Excellent critical thinking, using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
  • Active learning – understanding the implications of new information for both current and future problem solving and decision making.
  • Excellent time management.
  • Strong computer skills: MS Word, MS Excel (chart, pivot tables), PowerPoint, and database management.

Level of Experience:

  • A minimum of 5 years of Quality and/or Regulatory experience in an FDA regulated and/or ISO certified facility (preferably ISO 13485).

Level of Education:

Bachelor degree or equivalent work experience.

Travel:

Occasional overnight travel

Up to 10%

Essential Duties and Responsibilities

The core tasks, duties, and responsibilities that must be performed on the job.

 
  • The International Regulatory Manager is responsible for establishing and maintaining our global registrations and licenses.
  • Organize and track SunMed’s existing global registrations.
  • Develop a strategy with the International Sales team to grow our global footprint.
  • Coordinate efforts associated with the preparation of regulatory documents and submissions for International registrations.
  • Develop and conduct regulatory training related to International requirements.
  • Communicate with foreign distributors and regulatory agencies regarding pre-submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review.
  • Coordinate, prepare, or review regulatory submissions for international projects.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Participate in internal and external audits as it relates to global registrations, licensing, and requirements.
  • Recommend changes to technical documentation procedures in response to changes in International regulations or standards.

Other Responsibilities

  • Focus on achieving our Company mission
  • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality, compliance, and safety.
  • Inspire the trust of others; treat people with respect and dignity, and embrace the value of diversity.
  • Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
  • Contribute to building and maintaining a positive team environment.
  • Assure all policies and guidelines are implemented and followed.
  • Communication – Effectively providing information to supervisors and coworkers by telephone, in written form, email, or in-person.
  • Developing specific goals and plans to prioritize, organize, and accomplish your work.
  • Analyzing information and evaluating results to choose the best solution and solve problems.
  • Developing constructive and cooperative working relationships with others, and maintaining them over time.
  • Performing day-to-day administrative tasks.
  • Getting members of our organization to work together to accomplish tasks.
  • Training others on the importance and requirements related to technical files and documentation.

Quality Policy:

 

At SunMed, quality is our promise.

 

It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market.

 

The promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

The Inside Sales Account Manager will be responsible for the following:

  • Responsible for growth of business in specified target market, while hitting daily, weekly, and quarterly activity and sales metrics.
  • Recording all outbound call information: Contact, product opportunities, summary of discussion, setting follow up call date into CRM in the customer card section within Salesforce.
  • Act as the liaison between customers (hospitals, distributors, etc.) and SunMed
  • Making outbound calls, creating, and growing business relationships with customers - based on their specific needs and SunMed initiatives. 
  • Receiving and entering inbound customer phone orders and faxes as needed.
  • Other tasks as assigned by manager.

Essential Duties and Responsibilities

The core tasks, duties, and responsibilities that must be performed on the job.

 
  • Outbound calling to existing and potential customers for the purpose of increasing sales
  • Providing price, quote, availability, and conditions/terms of sale.
  • Initiating and maintaining customer profiles within SunMed’s CRM (Salesforce).

Other Responsibilities

  • Focus on achieving our Company mission
  • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
  • Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
  • Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
  • Contribute to building and maintaining a positive team environment.

Assure all policies and guidelines are implemented and followed.                                      

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance.  These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.

Commonly accepted business practices within a customer care position.

Skills & Abilities:

This role requires an individual that is coachable and open to learn. Individual is required to manage all facets of the sales cycle, including preparing presentations for customers, creating quotes for specific items, taking new orders, strategically researching, and discovering new product solutions SunMed can provide, and leveraging contract positions within facilities.  Position requires a personable attitude, with an ability to cheerfully manage a complete spectrum of customer needs including those where the customer may be displeased with service received. Individual is required to be knowledgeable of the product line, so that they can adjust and meet the needs of the customer as they develop. Individual must be able to confidentially handle transactions involving customer’s financial information and be aware of corporate expectations handling this information. Individual is required to be knowledgeable of corporate policy.

This is an inside role with an assigned customer base. This is not a role that strictly uses outbound cold calls to generate leads. Managing an existing base of business while focusing on new product growth is expected. Must be comfortable managing relationships at multiple levels of an organization. Identify market trends and managing distribution relationships to support customers is required.

Level of Experience:

1-3 year of sales experience preferred

1-3 years of medical sales experience a preferred

Experience with CRM (Salesforce, HubSpot, Microsoft Dynamics, Oracle, etc.)

Excellent verbal, interpersonal communication, and phone skills

Above average Excel proficiency preferred

Level of Education:

Bachelor’s degree preferred

Travel: Minimal: 1-2 single overnight regional trips per year.

Quality Policy:

At SunMed, Quality is our promise.  It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

This position is located in Tucson AZ.  Must be able to work fulltime in Tucson AZ.

SunMed,LLC is a global market leader in the development, manufacturing, and distribution of specialized disposable and reusable medical devices used in Respiratory Care, Anesthesiology, Neonatal & Pediatric, EMS and Home Care. The company’s primary product focus is in Pulmonary Medication Delivery, Oxygen Delivery, Airway Management, Gas Delivery, Heated Humidification, Arterial Blood Collection, Capnography, Resuscitation and Wound Prevention.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • New tool construction from concept to completion
  • Assist in Tooling Design, Fixture Design, and any other tooling related requirements.
  • Assembling of molds and getting them ready for testing. Verify fits and functionality of all mechanisms, sliding components, and cooling system. Complete inspections of the cores/cavities to verify proper shut offs and dimensions.
  • Troubleshoot issues if they arise and develop plans to resolve. Adjustments of final fits and components to ensure the mold will perform in testing and production.
  • Perform mold disassembly/assembly and machining tasks to develop/fine tune molds, repair molds, and make engineering changes.
  •  Assist others to complete molds, repairs, as requested.
  • Participate in continuous improvements efforts to improve operations and mold making process.
  • Interface with Molding Department/Maintenance/P.M Tool room
  • Able to design and build new and replacement parts without prints.
  • Documentation on mold repairs, modifications, new designs
  • Establish and maintain toolroom machine maintenance and shop cleanliness.
  • Multitask jobs as required.
  • Running of multiple machines to keep workflow moving.
  • Able to run and work with little or no supervisions on all machines in tool room.
  • Able to work with little or no supervision.
  • Assist in Tooling Design, Fixture Design and any other tooling requirements needed.
  • Preventive maintenance on ejection molds
  • Weekend and weekday support is required on your rotation and at times you will be required to come in on off rotation shifts.
  • Travel to our Mexico facilities at times for support is possible.
  • Perform hands on machining tasks using blueprints, CAD files, written, and verbal work instructions. You are responsible to operate the equipment in a safe manner and to achieve the required dimensional accuracy.
  • Interface with other personnel to assist in the routing, planning, work instructions, problem solving, and expediting of molds and components on assigned jobs.
  • Develop a plan for your activities, identify risks to completion, establish work priorities, set milestone goals, regularly assess the progress on the job, and escalate issues that will affect delivery.
  • Monitor the status of the incoming components of your molds and communicate as necessary with the purchasing team to verify you will have the components when required to meet delivery.

Skills

  • Comprehensive knowledge of molds design types, the fit and function of various types of actions, lifters, ejection systems, mold cooling components, latch lock systems, hot runner systems, mold interlocks, guiding systems, auto unscrewing system, etc.
  • Possess a wide range of hands-on precision machining skills on grinders, mills, lathes, and other metal working equipment.
  • Excellent measurement and analytical skills to accurately measure cores and cavities with many types of tools to tolerances as close as +/-.0001”
  • Experience using all of the tools required when assembling, hoisting, and moving molds
  • Good basic computer skills with the ability to be trained

QUALIFICATIONS:

  • Journeyman Card
  • Minimum 10 years mold making experience.
  • Experience in ISO medical regulated environment
  • Read, write, and communicate in English.
  • Must have own tools.
  • Ability to travel into Mexico
  • Must work positively and constructively with fellow employees.
  • Must be able to lift 50 lbs. un-assisted, walk long distances and stand for prolonged periods of time.

This position is responsible for managing complex engineering projects ranging from high visibility cost savings activities to world-class product and processes improvements to medical devices.  Interaction and continuous communication with various manufacturing facilities in the USA, Mexico, and China will be a key part of the design and validation processes.  Additionally, this position will assist with other day to day engineering activities ranging from product line extensions, product improvements, and quality enhancements to support internal and external customer requirements.

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance.  These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.

The ideal candidate for this position will have knowledge of the design and development processes used for medical devices.  Experience with manufacturing processes for plastic components such as injection molding knowledge is preferable.

Skills & Abilities:

The candidate will have the ability to work with mathematical concepts and apply those concepts to practical situations; proficiency with standard computer software.  Knowledge of CAD software is required, and experience with Solidworks is desired.

Level of Experience:

7 + years of experience in an engineering position.  Experience in a medical device, pharmaceutical, or plastics manufacturing facility is a plus.

Level of Education:

The position requires the candidate to at least have a Bachelor’s Degree in manufacturing, industrial, or mechanical engineering.

Travel:  The amount of time required for this position will depend on specific project requirements.

Location- El Paso TX.

Provide customer service and sales support.  Coordinate product sales related activities.  Perform a variety of departmental functions related to sales and customer service.

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance.  These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.

Knowledge of sales techniques and terminology required.  Intermediate to Advanced MS OFFICE experience. 

Two to four years of experience is a customer service position is required.  Ability to work in a fast paced environment.  Ability to manage multiple projects/issues simultaneously.

Level of Experience:

Minimum 2 years experience in a customer service position.

Level of Education:

Minimum requirement is some college experience. Associates degree preferred.

Travel: Amount of travel availability required for position.

Less than 10%.  There may be an occasional requirement for overnight travel for tradeshows, training, or customer visits.

Responsible for the oversight and management of the accounts payable function. Responsible for treasury function for the Company, including daily banking activities, sales tax and excise tax filings, and cash flow management.  This position is also a lead in the activities of the general accounting function.  This includes developing, implementing, and maintaining accounting systems and processes; confirming adherence to procedures and policies; and ensuring financial statements are in accordance with Generally Accepted Accounting Principles (GAAP).  

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance.  These competencies are generally demonstrated through specific service, education, or training.

DESIRED SKILLS AND EXPERIENCE

  • Bachelor Degree in accounting required
  • Career focus in finance or accounting (4 to 5 years minimum)
  • Systems expertise (ERP systems, excel, database)
  • Experience managing a team of 3-6
  • Ability to work cross-functionally
  • Strong interpersonal and communication skills
  • Strong organizational skills

Essential Duties and Responsibilities

The core tasks, duties, and responsibilities that must be performed on the job.

PRIMARY RESPONSABILITIES

  • Manages treasury processes, including daily banking activities and cash flow reporting.
  • Supervises accounts payable department, including ensuring timely payment of vendor invoices.
  • Leads monthly financial close process, including preparation and review of journal entries and subsidiary ledgers.
  • Identifies and implements process improvements to enhance efficiency and controls.
  • Ensures adherence to GAAP policies and procedures.
  • Performs monthly Balance Sheet Account Reconciliations and related analysis.
  • Supports PWC audits and implements recommendations for improvement.
  • Executes tax filings and returns for property tax, sales tax, and other state tax requirements.
  • Provides on-going compliance support in areas of tax and governmental reporting.
  • Supports integration and accounting for newly acquired businesses.

Other Responsibilities

  • Focus on achieving our Company vision and goals.
  • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
  • Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
  • Contribute to building and maintaining a positive team environment.
  • Assure all policies and guidelines are implemented and followed.

Quality Policy:

SunMed is committed to excellence and the highest level of customer satisfaction for all products and processes. We are committed to the delivery and support of safe and effective anesthesia, respiratory and urology devices through:

Excellence

  • We are dedicated to providing the quality of excellence through teamwork, leadership, open communication and continuous improvement to achieve the company’s objectives and meet our customer’s expectations.
  • Continuously improve the effectiveness of our Quality Management System that delivers compliant and sustainable products, processes and systems.

Customers

  • We will adapt to customers changing needs at all times in an environment of continuous improvement of high quality products and services.

Products

  • We distribute products that are safe, reliable and in compliance with applicable US and International regulatory requirements, standards and regulations.