Senior Medical Device Compliance Engineer

TL;DR

Senior Medical Device Compliance Engineer (Medical Devices/Design Controls): Ensuring design control execution and post-market compliance for electromechanical medical devices with an accent on risk management, audit-ready documentation, and global regulatory requirements. Focus on building compliant Design History Files, managing verification and validation, assessing product changes, and supporting supplier and regulatory audits.

Location: Needham, Massachusetts, United States

Salary: $87,800–$150,000 USD annually

Company

Global product design and technology company developing consumer lifestyle products and medical devices under the Shark and Ninja brands.

What you will do

• Drive design control execution across multiple concurrent medical device new product development programs.
• Create, review, and approve Design History Files, including requirements, design reviews, risk management, verification and validation, and traceability documentation.
• Translate regulatory and compliance requirements into actionable product and engineering requirements.
• Lead risk management activities, including hazard analysis, DFMEA, test planning, and lifecycle risk reassessment.
• Support post-market changes through ECNs, root cause analysis, verification and validation, and documentation updates.
• Review supplier qualifications, process validations, and manufacturing documentation while supporting audits and regulatory inspections.

Requirements

• Bachelor’s or Master’s degree in Engineering, Quality, Biomedical Engineering, or a related technical discipline.
• 5+ years of experience with medical device design controls and post-market sustaining.
• Hands-on experience with electromechanical medical devices in consumer electronics or high-velocity product development environments.
• Deep knowledge of ISO 14971, hazard analysis, DFMEA, requirements management, verification, and validation.
• Experience with post-market design changes, ECNs, root cause analysis, and lifecycle risk management.
• Experience with overseas contract manufacturers and distributors, including qualification and process validation review.

Nice to have

• Working knowledge of biocompatibility, electrical safety, labeling, and component change impact assessments.
• Experience operating in a complex, matrixed organization.

Culture & Benefits

• Fast-paced, innovation-driven product development environment.
• Medical, dental, and vision insurance, plus HSA and FSA options.
• 401(k) retirement plan with company matching and employee stock purchase program.
• Paid time off, company holidays, parental leave, and disability insurance.
• Learning programs, wellness support, product discounts, and additional family and legal benefits.
• Commitment to diversity, equity, inclusion, and professional growth.