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 includes identifying process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• The successful candidate will be eligible for annual bonus and long-term incentive, and the company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days.

Matching Summary

Salary

Base: $153,800.00 - $242,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Key Requirements

• B.A./B.S. in Engineering plus 15 years experience or Master’s plus 12 years
• 10+ years in process improvement and quality management
• experience with combination products and medical devices
• knowledge of FDA and global medical device regulations
• experience leading DHF deliverables
• PMP or similar project management certification preferred
• Six Sigma Certification preferred
• Quality Engineering Certification preferred
• VISA sponsorship available

Work Rights