This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance
Job Summary
This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.
The role will also be responsible for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products.
The salary range for this role is $153,800.00 - $242,200.00.
Matching Summary
This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.
Salary
Base: $153,800.00 - $242,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision healthcare and other insurance benefits, retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
Skills & Requirements
Must-have
combination product design controls
risk management processes
operational excellence tools
ISO 13485
ISO 14971
Nice-to-have
influence without formal authority
drive continuous improvement
foster cross-functional collaboration
strategic thinker
Key Requirements
15 years of related experience with B.A./B.S.
12 years of related experience with Master's degree