Senior Medical Device Compliance Engineer - Fast-Paced NPD

Ninjakitchen; Needham (MA); On-site; USD 88,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) matching

Product discounts

Job summary

SharkNinja in Needham, MA is seeking a Senior Medical Device Compliance Engineer to own design controls and post-market sustaining activities across its Medical Devices portfolio.

You will ensure global regulatory compliance, lead DHF reviews, risk management, and ECN processes, collaborating with Engineering, Legal, Program Management, Quality, and overseas manufacturers to deliver safe, compliant medical devices.

Qualifications

• Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Biomedical), Quality, or 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.

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.

Skills

Design controls

Risk management

Regulatory compliance

Cross-functional collaboration

Communication skills

Education

Bachelor’s or Master’s in Engineering

Job description

SharkNinja in Needham, MA is seeking a Senior Medical Device Compliance Engineer to own design controls and post-market sustaining activities across its Medical Devices portfolio.

You will ensure global regulatory compliance, lead DHF reviews, risk management, and ECN processes, collaborating with Engineering, Legal, Program Management, Quality, and overseas manufacturers to deliver safe, compliant medical devices.