Jobs

POSTED 3.9.12

MANAGER ** Regulatory Affairs ** Medical Diagnostic Devices

	Are you a medical device compliance expert with project management and leadership skills?
	Do you have a passion for quality?
	And, would you thrive in an entrepreneurial, energetic company?

COMPANY:
Polymer Technology Systems, Inc. (PTS) is a well-established life sciences business with a global presence. Our revolutionary medical diagnostic devices test cholesterol and other indicators in the blood for cardiovascular disease, diabetes, and other chronic conditions. Launched worldwide in 2003, our CardioChek® family of diagnostic devices is now used by thousands of physicians, pharmacists, and wellness programs around the world. PTS is committed to the ongoing development of innovative products that enable people to assess risk and monitor therapeutic progress on-the-spot.

OPPORTUNITY:
As our Manager of Regulatory Affairs, you will coordinate and facilitate regulatory submissions and registrations for new products. This is coordinated with the development efforts for new products and with the sales and marketing plan, on a country and regional basis. Provide advice and strategic planning with regards to compliance issues related to the FDA and Ex-US regulatory requirements pursuant to FDA Code of Federal Regulations and EU in Vitro Device Directive, ISO and CE Mark requirements. Reporting directly to the V.P. of Quality and Regulatory Affairs, you will work with a cross functional team (R & D, Head of Quality, Sales and Marketing, and Product Support) while taking ownership of all submission processes.

KEY ACCOUNTABILITIES:

	Files and updates 510 (k)’s, CLIA submissions, and FDA correspondence.
	Together with the Head of Regulatory, Clinical and Technical Affairs, develops a strategic plan for product approval and registration purposes.
	Develops the master timeline and schedule for US-FDA product registrations and submissions.
	Consults with R & D and Product Support to develop protocols for clinical evaluations to meet submission requirements.
	Coordinates with department heads in R & D, Product Support, Head of Regulatory, and Manager of Clinical and Technical Affairs to collect technical data to support submissions.
	Develop draft labeling for product lines.
	Draft appropriate reports, processes internal reviews and approvals.
	Ensure all applicable laws, regulations, and compliance issues are understood throughout the organization.

SUCCESS FACTORS:

	Minimum 3 years of experience working in a regulatory submissions or compliance capacity in a regulated medical industry, preferably the Medical Devices industry
	A Bachelor’s degree in Biology, Chemistry, Medical Technology or related field required.
	Master’s degree preferred.
	High level of multi-task management and be able to use program management tools such as MS Project and MS Excel.
	Thorough understanding of FDA Medical Device Reporting and EU Medical Device Vigilance Reporting.
	Detail oriented and ability to document effectively and completely.
	Excellent communication skills, both written and verbal.
	Must have the ability to interact with numerous internal and external customers as the “face of the business” including regulatory agencies
	Able to mentor others within the organization regarding regulatory requirements
	Desire to succeed in a growing, entrepreneurial company!

COMPENSATION AND BENEFITS:
Polymer Technology Systems, Inc. will reward your talents with a total compensation package commensurate with experience. You will also receive a generous benefits package including medical benefits, dental, flexible medical spending account, life insurance, LT disability, PTO, and 401(k) retirement plan with company match.

APPLY NOW:
If you are a medical device compliance expert with leadership skills, we encourage you to apply online now at Search27@safarisolutions.com. If you choose to attach your resume via email, please format your documents in MS Word.

To learn more about Polymer Technology Systems, please visit www.cardiochek.com.

Polymer Technology Systems requests that all candidate communication and recruiter inquiries be directed to Safari Solutions.

POSTED 3.9.12

MANAGER ** Clinical Product Evaluations ** Medical Diagnostic Devices

	Are you a medical device compliance expert with project and people management skills?
	Do you have a passion for accuracy and quality?
	And, would you thrive in an entrepreneurial, energetic company that is experiencing consistent growth?

OPPORTUNITY:
As the Manager of Clinical and Technical Support you will coordinate and execute clinical and field evaluations of both current products as well as innovative new product s under development. This position serves as a “voice of the customer” to our development team lending valuable customer needs and requirements to product definitions. The manager also assists with routine sales evaluations and provides detailed technical advice to internal (PTS staff) and external customers. Your overall goal is to ensure our products are utilized as intended with accurate outcomes in clinical environments. The ability to document the product performance in abstracts, technical reports and manuscripts is critical. Your ability to keep our technical staff up to date as well as be vigilant to compliance issues and user complaints will ensure we maintain our reputation for “Quality in everything we do.” Reporting directly to the V.P. of Quality and Regulatory Affairs, you will work with a cross functional team while taking ownership of all evaluation processes.

KEY ACCOUNTABILITIES:

	Oversee external evaluations of new and redesigned products domestically & internationally.
	Compile and analyze evaluation data in order to generate formal reports.
	Develop and implement protocols for clinical evaluations.
	Prepare and draft manuscripts and abstracts for peer review.
	Prepare and execute clinical evaluations for US and Ex-US product approvals.
	Serve as the Voice of the Customer in product design efforts,
	Coordinate development of technical bulletins.
	Create technical files and product design history files, according to the requirements of ISO and IVDD.
	Review all documentation and track trends regarding complaints and inquiries from both internal and external customers.
	Trend complaints from both internal and external customers.
	Provide technical training for Customer Service, Technical Support, & Sales.

SUCCESS FACTORS:

	Minimum 10 years of experience in the medical diagnostic device or related regulated industry.
	A Bachelor’s degree in Biology, Chemistry, Medical Technology or related field required.
	Knowledge of clinical environments in which PTS products are used such as doctors’ offices, hospitals, and clinics.
	An understanding of the clinical use of Point-of-Care testing is desirable.
	Working experience of QSR and IVDD preferred.
	Experience with statistical techniques.
	Management experience with the ability to mentor and train others.
	Detail oriented and results focused.
	Excellent written and verbal communication skills.
	Able to travel domestically and internationally
	Desire to succeed in a growing, entrepreneurial company!

COMPENSATION AND BENEFITS:
Polymer Technology Systems, Inc. will reward your talents with a total compensation package commensurate with experience. You will also receive a generous benefits package including medical benefits, dental, flexible medical spending account, life insurance, LT disability, PTO, and 401(k) retirement plan with company match.

APPLY NOW:
If you are a medical device compliance expert with leadership skills, we encourage you to apply online now at Search26@safarisolutions.com. If you choose to attach your resume via email, please format your documents in MS Word.

To learn more about Polymer Technology Systems, please visit www.cardiochek.com.

Polymer Technology Systems requests that all candidate communication be directed to Safari Solutions.

POSTED 3.2.12

Director of Engineering ** R&D ** Medical Devices - Diagnostic

	Are you internally driven and results oriented?
	Are you a natural born leader that manages and leads by example?
	And, would you thrive in an entrepreneurial, energetic company that is experiencing growth?

COMPANY:
Polymer Technology Systems, Inc. (PTS) plays an active role in the life sciences industry. Launched worldwide in 2003, our revolutionary diagnostic medical device, CardioChek®, provides point of care testing for lipids and checks cholesterol and other indicators in the blood for cardiovascular disease, diabetes, and other chronic conditions. Our CardioChek® system has screened over 50 million people in over 104 countries around the world and serves physicians, pharmacists, and wellness programs. PTS is committed to the ongoing development of innovative products that enable people to assess risk and monitor therapeutic progress on-the-spot. This is an exciting time to join the PTS team, as we are gaining traction throughout the global marketplace!

OPPORTUNITY:

As our Director of R&D Engineering, you will have R&D engineering responsibility and program management of our CardioChek® platform, a state of the art Point of Care diagnostic system. As we continue to expand and improve our platform, you will be responsible for the management of the engineering staff, reconciliation of mechanical, electrical, and IT system configuration needs, and maintenance of the CardioChek® system. Reporting to the Chief Science and Technology Officer, and working in conjunction with the Director of Biochemical R&D and the marketing team, you will ensure product improvement projects are well planned and executed to timely completion.

KEY ACCOUNTABILITIES:

	Lead responsibility for all engineering aspects of the CardioChek® system including mechanical, electrical, software, and firmware.
	Work with marketing to define the requirements for CardioChek® system improvements and developments.
	Survey and select external design and development partner.
	Provide engineering and program management leadership to cross-functional development team and provide overall corporate leadership to product and process improvements.
	Identify resource needs, reconcile resources conflicts, and adapt development.
	Work with internal partners to ensure project meets defined marketing and regulatory requirements.
	Ensure development programs meet the Design Control Criteria and all engineering programs are in compliance within the Quality Systems Regulations which govern the In Vitro Diagnostic Directive (IVDD).

SUCCESS FACTORS:

	8+ years of medical device or diagnostic industry experience.
	3+ years’ experience of managing complex and/or multiple projects.
	Bachelor’s degree in an Engineering field.
	Advanced scientific, technology and, and/or business degrees desirable.
	Engineering expertise in a medical device (diagnostic) business and
	Proven track record of engineering and system development.
	Demonstrated success defining and executing product development processes in conjunction with medical device industry standards.
	Outstanding leadership qualities who communicates well and excels in changing, high-impact environment.
	Solid understanding of IT connectivity pertaining to software/firmware.
	Internally driven with desire to drive results.

COMPENSATION AND BENEFITS:

Polymer Technology Systems, Inc. will reward your talents with a salary of $90k to $100k commensurate with experience. You will also receive a generous benefits package including medical benefits, dental, flexible medical spending account, life insurance, LT disability, PTO, and 401(k) retirement plan with company match.

APPLY NOW:

If you are a leader that delivers results, we encourage you to apply online now at Search7@safarisolutions.com.

To learn more about Polymer Technology Systems, please visit www.cardiochek.com.

Polymer Technology Systems requests that all candidate and recruiter inquiries be directed to Safari Solutions.

Drew Smith, HR Consultant

Safari Solutions

POSTED 3.2.12

PRODUCTION PLANNER ** Operations ** Medical Devices

	Do you have a “quality in everything you do” attitude?
	Do you enjoy planning and preparing?
	And, would you thrive in an entrepreneurial, energetic company that is experiencing consistent growth?

COMPANY:
Polymer Technology Systems, Inc. (PTS) has played an active role in the life sciences industry since 1992. Our revolutionary diagnostic medical device provides point of care testing for lipids and checks cholesterol and other indicators in the blood for cardiovascular disease, diabetes, and other chronic conditions. Launched worldwide in 2003, our CardioChek® system has screened over 50 million people in over 104 countries around the world and serves physicians, pharmacists, and wellness programs. PTS is committed to the ongoing development of innovative products that enable people to assess risk and monitor therapeutic progress on-the-spot. It is an exciting time to join the PTS team, as we are gaining traction throughout the global marketplace.

OPPORTUNITY:

As our Production Planner, use your planning skills to ensure that customer demand is satisfied and expectations are met in all aspects of product availability. You will champion the master production schedule, membrane availability, MRP generation and safety stock. Reporting to the Supply Chain Manager, alert supervisors to potential compliance situations with proactive vigilance!

KEY ACCOUNTABILITIES:

	Implement MRP planning using MAS.
	Plan and prepare master and daily production schedules for strip and meter production.
	Manage the sequence, lead-time and workflow for each operation to meet shipping dates.
	Analyze production and plant capacity to determine manufacturing process and labor requirements.
	Allocate membranes, establish lot numbers and expiration dates.
	Work closely with the purchasing specialist to ensure raw material availability to meet the master schedule.

SUCCESS FACTORS:

	Minimum 2 years’ experience as a Production Planner.
	High School diploma required; Bachelor’s degree preferred.
	Experience using ERP & MRP systems.
	Experience setting up and maintaining MRP data and planning parameters.
	Proven leadership skills with ability to influence cross-functional teams without formal authority.
	Able to manage multiple projects and timelines, and deliver on-time and on-budget.
	Demonstrated success of meeting customer and inventory requirements.
	Superior written and verbal communication and presentation skills.
	Proficient in MS Word, PowerPoint, and Excel.

COMPENSATION AND BENEFITS:

Polymer Technology Systems, Inc. will reward your talents with a salary of $40k to $45k commensurate with experience. You will also receive a generous benefits package including medical benefits, dental, flexible medical spending account, life insurance, LT disability, PTO, and 401(k) retirement plan with company match.

APPLY NOW:

If you are a proven Production Planner, we encourage you to apply online now at Search10@safarisolutions.com.

To learn more about Polymer Technology Systems, please visit www.cardiochek.com.

Polymer Technology Systems requests that all candidate and recruiter inquiries be directed to Safari Solutions.

Drew Smith, HR Consultant

Safari Solutions

POSTED 3.2.12

MARKETING ASSOCIATE ** Medical Device ** Labeling

	Can you creatively stretch marketing limits without losing functionality?
	Do you enjoy designing for both print and web?
	Are you looking for a progressive, growing company that values your opinions and creativity?

COMPANY:
Polymer Technology Systems, Inc. (PTS) has played an active role in the life sciences industry since 1992. Our revolutionary diagnostic medical device provides point of care testing for lipids and checks cholesterol and other indicators in the blood for cardiovascular disease, diabetes, and other chronic conditions. Launched worldwide in 2003, our CardioChek® system has screened over 50 million people in over 104 countries around the world and serves physicians, pharmacists, and wellness programs. PTS is committed to the ongoing development of innovative products that enable people to assess risk and monitor therapeutic progress on-the-spot. It is an exciting time to join the PTS team, as we are gaining traction throughout the global marketplace.

OPPORTUNITY:

As our Marketing Associate, you will use your creative talents to develop graphic design collateral materials and create marketing/sales packaging, labeling, brochures, letterheads, envelopes, business cards, website, and tradeshow graphics. Reporting to the Vice President of Marketing, you will establish event marketing relationships, coordinate tradeshow events, and establish the Pre-ECN Document Control process that will support internal and external marketing communications. And, as internal support for our sales force, you will develop and maintain internal sales training materials. Your skills will be instrumental in arranging tradeshow participation and producing advertising, and public relations materials.

KEY ACCOUNTABILITIES:

	Labeling experience including preparation of files/uploading to FTP sites.
	Daily sales support including registration and logistics for trade shows.
	Managing ECN Regulatory Process for document approvals.
	Creative writing and editing skills.

	Prepare all print and electronic marketing proofs and materials.
	Establish a process to support worldwide marketing communications.
	Create graphic designs for all internal/external sales and marketing collateral, specifically with packaging and labeling design work.
	Manage assigned events marketing relationships and coordinate tradeshows.
	Organize a healthcare screening process for events.
	Provide event marketing information for sales training.
	Assist in contacting and arranging tradeshow participation, advertising, and public relations material.

SUCCESS FACTORS:

	2-3 years of experience in graphic design packaging and labeling.
	Bachelor’s degree in marketing/graphic design or related field required.
	Knowledge of regulatory labeling requirements for medical devices required.
	Working knowledge of Joomla for web-site editing.
	Demonstrated skills in developing and executing marketing processes.
	Excellent knowledge of Adobe Creative Suite including Illustrator, InDesign, Photoshop, Acrobat & Quark.
	Tech savvy with MS Office experience including PowerPoint presentations.
	Proactive work ethic with the ability to “deliver results.”
	Multi-task capable – works well independently or as team member.

COMPENSATION AND BENEFITS:

Polymer Technology Systems, Inc. will reward your talents with a competitive base salary and a generous benefits package including medical benefits, dental, flexible medical spending account, life insurance, LT disability, PTO, and 401(k) retirement plan with company match.

APPLY NOW:

If you are a creative designer that enjoys working collaboratively with other team members, we encourage you to apply online now at Search10@safarisolutions.com.

To learn more about Polymer Technology Systems, please visit www.cardiochek.com.

Polymer Technology Systems, Inc. requests that all candidate communication be directed to Safari Solutions.

Drew Smith, HR Consultant

Safari Solutions

Search31@safarisolutions.com

Posted 12.5.11

Position: QA8861-Principal Quality Engineer

Location: Warsaw, IN

Job Summary

Responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer to implement Zimmer Quality goals.

Principal Duties and Responsibilities

Evaluating process methods and equipment to meet performance and quality requirements.

Establishing quality plans for equipment and processes for general and specific product performance needs

Monitoring performance of processes to a standards

Applying ISO and QSR requirements to processes and procedures for Zimmer and outside suppliers; Working with suppliers on new product introduction to insure that quality and performance requirements are fulfilled

Assisting Manufacturing, Sourcing and Development in the interpretation and application of regulations

Developing and maintaining department and project budgets

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e. KSAs)

* Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).

*Facilitates team efforts on quality engineering projects.

* Ability to deliver, meet deadlines and have results orientation.

* Able to communicate both orally and in written form to multiple levels of the company.

* Understanding of QSR/ISO regulations, design assurance, FMEA.

* Knowledge of statistics, process control, and process capability

* Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.

* Thorough knowledge base of existing Zimmer products and a basic understanding of competitive products

Education/ Experience Requirements

* B.S. in engineering or an alternative Bachelor's degree program

* Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred but not required

* 4+ years experience in Engineering focused in one of the following areas, Quality, Quality Assurance, Manufacturing, Development, Regulatory or Compliance

* 4+ years FDA regulated industry experience required.

* Combination of education and experience may be considered. Minimum of a Bachelors

Travel Requirements

* Up to 20%

Apply Online Zimmer-Principal Quality Engineer

Candidates may also feel free to reach out to dan.gilland@zimmer.com

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EMPLOYMENT LISTINGS Please submit your job listings or jobs being sought for publication on this site. Information may be submitted via e-mail by clicking submit. Thank you!

EMPLOYMENT LISTINGS

Please submit your job listings or jobs being sought for publication on this site. Information may be submitted via e-mail by clicking submit. Thank you!