Job Summary

• This role involves applying Quality Engineering expertise to cutting-edge new products and essential product maintenance initiatives within the global medical technology sector.
• The position requires ensuring all design control and production projects meet local and international regulatory requirements including FDA and EU MDR standards.
• Candidates will have the opportunity to lead project quality from inception through launch while collaborating cross-functionally on multidisciplinary teams.

Matching Summary

Salary

Base: $110,200.00 - $176,400.00 USD Annual; Bonus/Equity: Annual Bonus Potential and Discretionary LTI Bonus; Benefits: Comprehensive health, dental, vision, 401(k), and wellness programs

Skills & Requirements

Key Requirements

• Bachelor's degree in Engineering with 5 years experience OR Master's with 3 years
• Knowledge of FDA medical device regulations (21 CFR Part 820)
• Proficiency in ISO 13485, ISO 14971, and MDSAP standards
• Ability to independently determine solutions and guide junior developers
• Experience with statistical analysis tools like DOE and SPC

Work Rights