Newly created role with a very exciting Medical Device client in the San Francisco Bay Area! Looking for a new challenge with a company growing year on year? Read on to find out more...
The Role:
- The Sustaining Quality Engineering Manager will provide leadership for the Hardware and Software lifecycle management teams of a Medical Device manufacturing site.
- Supports teams to ensure that existing products are designed, developed and manufactured in accordance with guidelines and execute initiatives for continuity of supply chain, quality improvement, cost reduction, and product safety.
- Provides Quality Assurance support to functions with a focus on process validation, process improvements, post market sustaining activities, and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366 and IEC 60601
- The succesful candidate will be involved deeper in the design control process where they will ensure design transfer is successfully transitioned to manufacturing, thus ensuring a scalable process.
- This position monitors field issues such as patient harm or customer dissatisfaction and partners with suppliers for resolution.
Qualifications :
- Bachelor of Science degree in Electrical/Software Engineering. Master’s Degree preferred.
- Expertise within the Medical Device industry, preferably with Class III electromechanical medical device.
- 10+ years of hands on experience with Hardware and Embedded Software Design
- 2+ years of managerial experience
Candidates will need to be on site 3 days a week, open to local candidates or candidates considering relocation from within the US.
