Senior Medical Device Compliance & Quality Engineer

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with matching

Employee stock purchase plan

Life insurance

Paid time off

Parental leave

Product discounts

Job summary

Senior Medical Device Compliance Engineer at SharkNinja in Needham, MA leads design controls and post-market compliance across SharkNinja’s Medical Devices portfolio. The role is hands-on and ensures medical device products are developed and maintained in compliance with global regulatory requirements within a fast-paced consumer electronics environment.

You will collaborate with Engineering, Product Development, Legal, Program Management, and Quality Engineering, including overseas

Qualifications

• Bachelor’s or Master’s degree in Engineering or 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, requirements management, and verification/validation.
• Experience working with overseas contract manufacturers and distributors.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Drive design control execution for multiple medical device NPD programs with audit-ready documentation.
• Lead DHF creation, review, and approval including risk management files and traceability.
• Translate regulatory requirements into actionable product and engineering requirements.
• Support post-market design changes, ECNs, root cause analysis, and lifecycle verification/validation updates.
• Serve as a hands-on QMS compliance leader within cross-functional teams.

Skills

Design controls

Risk management

Regulatory compliance

Communication skills

Education

Bachelor’s or Master’s degree in Engineering

Job description

Senior Medical Device Compliance Engineer at SharkNinja in Needham, MA leads design controls and post-market compliance across SharkNinja’s Medical Devices portfolio. The role is hands-on and ensures medical device products are developed and maintained in compliance with global regulatory requirements within a fast-paced consumer electronics environment.

You will collaborate with Engineering, Product Development, Legal, Program Management, and Quality Engineering, including overseas