Senior Product Safety and Compliance Engineer- Medical Devices

The role

The Senior Product Safety & Compliance Engineer leads certification projects from concept to mass production for medical devices and consumer products. This role involves managing regulatory filings, risk analysis, and partnering with global development teams to ensure market access.

What you will do

• Own certification activities and risk analysis for new product development projects.
• Lead preparation of regulatory filings including FDA 510(k) submissions and Technical Files.
• Maintain Design History Files in compliance with 21 CFR Part 820 and ISO 13485.
• Partner with Engineering, Quality, Industrial Design, Supply Chain, and Marketing.
• Own certification timelines, test lab capacity, sample plans, and certification budgets.
• Establish project needs and deliverables for product development teams and third-party partners.
• Execute risk management per ISO 14971.
• Drive usability engineering per IEC 62366-1.
• Lead weekly project reviews with decision-ready materials.
• Serve as subject matter expert on biocompatibility, software lifecycle, and electrical safety.

Required qualifications

• Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Systems, Materials, or a related engineering discipline).
• Hands-on experience on the design side of both product design and certification.
• Minimum 5+ years of compliance or design experience with consumer, commercial, or medical electromechanical products.
• Knowledge of IEC 60601-1 and applicable collateral/particular standards.
• Knowledge of ISO 14971.
• Knowledge of ISO 13485.
• Knowledge of IEC 62366-1.
• Knowledge of IEC 62304.
• Knowledge of ISO 10993 series.
• Knowledge of 21 CFR Part 820.
• Knowledge of EU MDR 2017/745.
• Knowledge of FDA 510(k) submission processes.

Nice to have

• RAC certification
• Experience interfacing directly with FDA, Notified Bodies, or accredited test laboratories.
• Familiarity with international medical device regulations for key markets (Health Canada, TGA Australia, ANVISA Brazil).
• Biomedical depth (ISO 10993, clinical evaluation)
• Systems depth (ISO 14971, design controls)
• Materials depth (REACH/RoHS, biocompatibility)
• Software depth (IEC 62304, embedded systems compliance)

Benefits

• medical insurance
• dental insurance
• vision insurance
• flexible spending accounts
• health savings accounts (HSA) with company contribution
• 401(k) retirement plan with matching
• employee stock purchase program
• life insurance
• AD&D
• short-term disability insurance
• long-term disability insurance
• generous paid time off

About the company

SharkNinja is a global product design and technology company with a portfolio of lifestyle solutions. Headquartered in Needham, Massachusetts, the company has more than 4,100 associates.