Senior Medical Device Compliance Engineer (Medtech)

TL;DR

Senior Medical Device Compliance Engineer (Medtech): Ensuring medical device design control and post-market compliance across the product portfolio with an accent on global regulatory requirements and high-velocity consumer electronics development. Focus on driving design control execution, creating audit-ready technical documentation, and managing risk activities including DFMEA and ISO 14971.

Location: United States (Needham, MA)

Salary: $130,500 - $159,500 USD

Company

Global product design and technology company specializing in disruptive lifestyle solutions across multiple consumer product categories.

What you will do

• Drive design control execution for multiple concurrent medical device NPD programs.
• Lead the creation, review, and approval of Design History Files (DHFs) and traceability matrices.
• Translate medical device compliance and regulatory requirements into actionable engineering requirements.
• Manage risk activities including hazard analysis, DFMEA, and test planning in alignment with QMS processes.
• Support post-market design changes by driving ECNs, root cause analysis, and risk reassessment.
• Oversee supplier qualifications and process validations from OEMs to ensure medical device compliance.

Requirements

• Bachelor’s or Master’s degree in Mechanical, Electrical, or Biomedical Engineering, or a related technical discipline.
• 5+ years of experience in design controls and post-market sustaining of medical devices.
• Deep expertise in ISO 14971, hazard analysis, DFMEA, and verification/validation.
• Experience working with overseas contract manufacturers and distributors.
• Knowledge of biocompatibility, electrical safety, and labeling.
• Must be based in the United States.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and company contribution.
• 401(k) retirement plan with matching and employee stock purchase program.
• Generous paid time off, company holidays, and parental leave.
• Additional perks including pet insurance, pre-paid legal insurance, and identity theft protection.
• Product discounts and referral bonus program.