Senior Medical Device Compliance Engineer

Senior Medical Device Compliance Engineer

Needham, MA, United States

The Senior Medical Device Compliance Engineer is responsible for medical device design control, and post-market compliance across SharkNinja’s Medical Devices portfolio. This role is hands-on and central to ensuring medical device products are developed and sustained in compliance with global regulatory requirements—while operating within a fast-paced, consumer electronics development environment.

In this role, you will hold yourself and cross-functional teams accountable for delivering best-in-class, safe, and effective medical devices that meet customer, business, and regulatory requirements. You will apply best practices and pragmatic, creative problem-solving to support high-speed product development, working closely with Engineering, Product Development, Legal, Program Management, and Quality Engineering, including overseas manufacturing partners.

Key Responsibilities

• 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, ensuring documentation is complete and submission ready.

• 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

Qualifications & Experience

• 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.