Senior Hardware Engineer

Our Milpitas, CA client seeks a Senior Hardware Project Engineer (Electrical Engineer)

This is a Direct Hire Opportunity.

ESSENTIAL FUNCTION:

1. Design, develop, and document electronic hardware for medical device systems that include an embedded microprocessor running a real time operating system, as well as User Input devices, including touch panel displays, and various signal input and output interfaces.

2. Must be capable of circuit design, generating schematics and performing board layouts, creating board assembly documentation and working with board houses to supply finished boards.

3. Work with board houses to specify and implement automated board test protocol and harness assembly testing.

4. Specify procedures and fixtures to test electronic medical devices.

5. Assist manufacturing in prototype and pilot builds of electronic medical devices. Serve as the lead technical resource for NPI product builds

6. Assist manufacturing in hardware problem analysis and solutions.

7. Assist in training of technicians and manufacturing staff on new products and procedures.

8. Prepare design verification and validation protocols for electronic medical devices.

9. Perform design verification and validation studies.

10. Familiarity with Electrical Safety Certification processes and the 60601 consensus standards.

11. Participate in design reviews for electronic medical devices.

12. Participate in FMEA and risk management reviews for electronic medical devices.

13. Perform product safety testing for regulatory submissions.

14. Evaluate and select development tools and equipment.

EDUCATION AND EXPERIENCE:

Typically requires a BSEE or equivalent. A MS degree is preferred. At least 12+ years of Medical Device experience or a BS/MS with 9+ years of Medical Device experience is required.