5900 First Ave S Seattle, Washington 98108 | Direct Hire
Position Title: Compliance Engineer
Position Description: Protingent Staffing has an exciting opportunity with our client in Seattle, WA. The Compliance Engineer will mentor engineers in all aspects of compliance submissions and oversee their submission activities, collaborate with production team to create and maintain submission documentation to support NRTL reports, collaborate with Quality Engineering in support of agency-related inspection activities and 3rd party safety agency (UL, TUV, NRTL) quarterly inspections, utilize your expertise in risk management and product safety certifications as a member of a multi-disciplinary team in assessing and reporting adverse events, and be an active participant in creating, maintaining, and updating Risk Files, Safety Files, and Usability Files for Natus NBC products.
- A champion for logical, critical thinking.
- Comfortable and confident in pushing back against multiple stakeholders in the interest of ensuring that Natus products are safe and meet requirements.
- A personable, skilled relationship builder who is able to coach and advise other team members on compliance and safety issues.
- Able to work effectively in an Integrated Product Team environment.
- Skilled at effectively communicating and collaborating with various contributors to get needed information and solve complex problems.
- Resourceful and proactive in doing research and accessing hard-to-find information.
- Self-motivated and able to manage their own work load.
- Well-versed in product safety requirements.
- A Bachelor’ s Degree in Electrical or Mechanical Engineering.
- A minimum of 8 to 10 years of experience, having completed at least 10 submissions, 5 of which for new products
- Working knowledge of the following industry regulations:
o IEC 60601-1 family of standards, including EMI/EMC requirements;
o IEC Standards 60950, 61010, and 62366;
o ISO 14971 for risk management; and
o EU Medical Device Directive 93/42/EEC.
- Experience with FDA Class 1 and Class 2 medical devices.
- Working knowledge of regulatory submission processes including FDA 510(k), Health Canada, and China SFDA.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.