Lead Product Compliance Engineer (Biotech)

San Francisco, CA

Job ID: 125356 Industry: Med

 

Lead Product Compliance Engineer (Biotech)

Environment:

Our client is a large biotechnology organization that develops and manufactures medical devices. This specific business unit focuses on Electronic  Test & Measurement  medical devices, and they are  currently seeking a Lead Product Compliance Engineer to support day-to-day activities.

 

Background and Responsibilities:

The Lead Product Compliance Engineer should come from an Electrical Engineering background and should have Medical Device experience. It is very important this individual has Analog Electronics/Analog Voltage experience.

Responsibilities will primarily include: evaluating product safety & compliance to applicable electrical safety/compliance regulations (including FDA, MDD, EMI/EMC,  and EU Low Voltage Directive.  The Lead Product Compliance Engineer will be responsible for developing compliance plans by evaluating/modifying/applying new & existing compliance engineering methodologies and qualifying vendors, components, and parts. They will determine compliance by establishing compliance test standards; conducting & witnessing tests; performing diagnostic procedures; measuring performance; analyzing and evaluating findings; performing analysis & troubleshooting of failures. In addition, this person will ensure proper compliance documentation is maintained by completing approval applications, recording test results, preparing investigative reports, preparing and filing Declarations of Conformity, and maintaining compliance database. Finally, this individual will ensure non-compliance issues are resolved by recommendations on product and process changes, and initiating engineering change orders (ECO’ s).

The Product Compliance Lead should also be familiar  with ISO 14971 (Risk Management). It would be a plus if this individual has EMC & Product Safety Certifications, IEC Technical Committee Membership, or is an ASQ Certified Quality Engineer. Also, experience working with High Vacuum Systems  is desired.

Required Experience:
  • Electrical Engineering
  • Analog Electronics
  • Medical Device  Product Safety & Compliance
  • Management Experience 

Plus:
  • EMC & Product Safety Certifications
  • IEC Technical Committee Membership
  • ASQ Certified Quality Engineer
  • High Vacuum Systems
  • ISO 14971

Job Type: Contract   

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