The Freudenberg Group, a global technology group with 48,000 employees in some 60 countries, develops leading-edge technologies, and excellent products, solutions and services for more than 30 market segments. Freudenberg & Co. Kommanditgesellschaft, with its Headquarter in Weinheim, is the strategic parent company of the broadly diversified Group. Freudenberg Medical is a leading global manufacturer of components for medical devices, complex catheter systems for minimally-invasive surgery and total solutions for the biotech, healthcare and pharmaceutical industries.

Sr Product Development Engineer - Test Method Development

Your tasks

  • Leads Design Verification activities to establish the safety and efficacy of medical device prototypes:
    • Designs and builds test fixtures
    • Evaluates, selects and sources test equipment
    • Develops and validates test methods
    • Authors test protocols and reports
  • Manages mechanical engineering laboratory:
    • Ensures lab complies with all applicable safety regulations
    • Maintains and calibrates lab equipment
    • Manages lab supplies
    • Provides equipment and test method training to other employees
  • Assists in other Design Controls activities (e.g. defining Design Input Requirements, preparing documentation).
  • Provides technical input for projects at all stages of the product life cycle.
  • May lead one or more product development projects.
  • Assesses new technologies and new product ideas for technical feasibility.
  • Selects materials for component parts and/or medical devices.

Our expectations

  • Bachelor of Science in Mechanical, Biomedical Engineering, or related discipline, advanced degree preferred.
  • 3 + years of post-graduate lab experience in a regulated environment.
  • Experience with tensile, compression and fatigue testing systems.
  • Experience with airflow and leak-testing systems is highly desired.
  • Experience developing and validating test methods.
  • Thorough knowledge of DOEs and statistical analysis principles (including Gage R&R).
  • Experience as a lab manager is a plus.
  • Experience with 3D solid modeling is preferred (e.g. SolidWorks or related software).
  • Familiarity with rapid prototyping techniques is a plus.
  • Working knowledge of MS Project is preferred.
  • Demonstrated experience with 21CFR Part 820.30 Design Controls, ISO 13485 and ISO 14971.
  • Medical Device experience required.
  • Green Belt certification in Lean or Six Sigma is preferred.
  • Strong mechanical, analytical and problem solving skills.
  • Creative with strong attention to detail.
  • Ability to manage multiple tasks with sometimes conflicting priorities.
  • Excellent written communication skills .
  • Good interpersonal skills to interact with engineers, vendors and team members.
  • Ability to work independently and with others in a fast-paced, results oriented environment.

Freudenberg Medical is a global leader in medical contract manufacturing we offer the following services for medical device, pharmaceutical and IVD clients worldwide: product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Freudenberg Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Costa Rica, Europe and Asia.

InHealth Technologies- In 1978, Drs. Blom and Singer pioneered the methods of tracheoesophageal voice restoration and valved silicone voice prostheses that for over the past 35 years have become the international standard for voice restoration, allowing thousands patients worldwide to regain their ability to speak. As a leading supplier of advanced voice restorations systems, our goal at InHealth is to help laryngectomies regain and preserve a vital part of their lives – their voice. InHealth is part of Freudenberg Medical.

Location: Carpinteria, CA

We are currently hiring for a Sr Product Development Engineer- Test Method Development who is:

  • Focused on customers and solving complex medical device development challenges in the ear, nose, throat, head and neck surgery (ENT/HNS) market segments.
  • Focused on technical detailed solutions and developing test methods, protocols and reports.
  • Self-motivated and thrives in a fast –paced, team-driven environment where you have the ability to interact with customers and support the development of innovative new products.

It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. Learn more at www.freudenbergmedical.com.  Also learn more about the InHealth Technologies products for the ENT marketplace at http://www.inhealth.com

Do you have any questions?

Freudenberg Medical - InHealth Technologies
Rachel Peterson ∙ Human Resources ∙ 1110 Mark Ave ∙ 93013 Carpinteria ∙ http://www.inhealth.com/Default.asp
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