Senior Medical Device Compliance Engineer

Senior Medical Device Compliance Engineer responsible for medical device design control, and post-market compliance across SharkNinja’s Medical Devices portfolio. The role involves hands-on QMS Compliance leadership within cross-functional teams, influencing execution through expertise, collaboration, and clear decision-making in a matrixed environment.

Requirements

• Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Biomedical), Quality, or a related technical discipline.
• 5+ years of experience in design controls, and post-market sustaining of medical devices
• Strong experience supporting electromechanical medical devices, preferably within consumer electronics or high-velocity product development environments.
• Deep expertise in design controls and risk management, including ISO 14971, hazard analysis, DFMEA, requirements management, and verification/validation.
• Experience supporting post-market design changes, including ECNs, root cause analysis, and lifecycle risk management.
• Experience working with overseas contract manufacturers and distributors, including qualification, process validation review, and ongoing compliance oversight.
• Working knowledge of biocompatibility, electrical safety, labeling, and component change impact assessments.
• Strong communication skills and the ability to operate effectively in a complex, matrixed organization.
• Pragmatic, detail-oriented mindset suited to fast-paced, innovative-driven environments.

Benefits

• medical insurance
• dental insurance
• vision insurance
• flexible spending accounts
• health savings accounts (HSA) with company contribution
• 401(k) retirement plan with matching
• employee stock purchase program
• life insurance
• AD&D
• short-term disability insurance
• long-term disability insurance
• generous paid time off
• company holidays
• parental leave
• identity theft protection
• pet insurance
• pre-paid legal insurance
• back-up child and eldercare days
• product discounts
• referral bonus program