Senior Medical Device Compliance Engineer

Shark Ninja is a global product design and technology company that develops 5‑star rated lifestyle solutions. The Senior Medical Device Compliance Engineer is responsible for medical device design control and post‑market compliance across Shark Ninja’s Medical Devices portfolio, working closely with Engineering, Product Development, Legal, Program Management, Quality Engineering, and overseas manufacturing partners.

• Drive design control execution for multiple concurrent medical device NPD programs, ensuring high‑quality audit‑ready technical documentation.
• Lead and support the creation, review, and approval of Design History Files (DHFs), including design and development plans, requirements, design reviews, risk management files, verification and validation plans and reports, and traceability.
• Translate medical device compliance and regulatory requirements into clear, actionable product and engineering requirements.
• Ensure risk management activities, including hazard analysis, DFMEA, and test planning, in alignment with QMS processes.
• Support post‑market design changes by driving and reviewing ECNs, root cause analysis, risk reassessment, and associated verification/validation and documentation updates.
• Serve as a hands‑on QMS compliance leader within cross‑functional teams, influencing execution through expertise, collaboration, and clear decision‑making in a matrixed environment.
• Review supplier qualifications, process validations, and manufacturing documentation from OEMs to ensure compliance with medical device requirements.
• Support internal audits, supplier audits, and regulatory inspections.

• 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.

Annual salary range: $130,500 – $159,500 USD.

Benefits include medical, dental, vision insurance; flexible spending accounts; health savings accounts with company contribution; 401(k) with matching; employee stock purchase program; life insurance; AD&D; short‑term and long‑term disability insurance; generous paid time off; company holidays; parental leave; identity theft protection; pet insurance; pre‑paid legal insurance; backup child and eldercare days; product discounts; referral bonus program.

We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability, or any other class protected by legislation, and local law. Shark Ninja will consider reasonable accommodations consistent with legislation, and local law. If you require a reasonable accommodation to participate in the job application or interview process, please contact Shark Ninja People & Culture at