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SharkNinja Logo SharkNinja · IT - Software Development

Compliance Engineer

United States, Needham Employment contract 72700.00 - 111400.00 USD / Year · Job Posted June 09, 2026
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Job Description

The Product Compliance Engineer will partner with global product developers and certification partners on regulatory compliance and product certification. The candidate will support certification projects from product concept to mass production, ensuring market access requirements are met and that product designs incorporate appropriate risk mitigation solutions. This includes participation in medical device regulatory pathways alongside our consumer and commercial product portfolio.

Job Responsibility

  • Support the execution of certification activities and risk analysis for multiple new product development projects, including FDA-regulated medical devices and products subject to EU MDR 2017/745
  • Assist in preparing regulatory filings including FDA 510(k) submissions and Technical Files/Design Dossiers, and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design Controls and ISO 13485 requirements
  • Support the establishment of project needs and deliverables for both product development teams and third-party regulatory partners, including Notified Bodies and FDA-accredited testing laboratories
  • Execute risk management activities in accordance with ISO 14971
  • Support usability engineering processes per IEC 62366-1
  • Evaluate project risk during the development process and support contingency planning
  • Participate in weekly reviews for all assigned projects
  • Assure that all activities related to product certification commence and execute as planned and on schedule
  • Support product development teams as a subject matter expert
  • Contribute to intradepartmental continuous improvement and special projects

Requirements

  • Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Computer Science, or a related technical discipline
  • RAC certification a plus
  • Minimum 2–4 years of compliance or design-related experience with consumer, commercial, or medical electromechanical products
  • Working knowledge of medical device regulatory standards including: IEC 60601-1 and applicable collateral/particular standards (esp. IEC 60601-1-2 for EMC, IEC 60601-1-6 for usability, IEC 60601-1-11 for home healthcare environments)
  • ISO 14971 – Risk Management for Medical Devices
  • ISO 13485 – Quality Management Systems
  • IEC 62366-1 – Usability Engineering
  • IEC 62304 – Medical Device Software Lifecycle (where applicable)
  • ISO 10993 series – Biocompatibility Evaluation
  • 21 CFR Part 820 – FDA Quality System Regulation
  • EU MDR 2017/745 – classification rules, Technical Documentation, and UDI obligations
  • FDA 510(k) submission processes
  • Familiarity with international medical device regulations for key markets (Health Canada, TGA Australia, ANVISA Brazil) preferred
  • Experience with DFMEA and medical-grade risk management documentation (hazard analysis, risk control verification, residual risk justification)
  • Exposure to or experience interfacing with FDA, Notified Bodies, or accredited test laboratories preferred
  • Must be able to operate comfortably in a fast-paced environment
  • Must be able to thrive under pressure and want to be continuously challenged
  • Must be able to manage multiple projects simultaneously
  • Must be able to multi-task
  • Must be able to present creative and technically sound solutions
  • Must like to solve puzzles
  • Must be able to analyze operations and support continuous improvement initiatives
  • Must be able to work with conviction while collaborating
  • Must be able to work and think with moderate supervision
  • Must be able to make sound decisions
  • Must be able to communicate complex technical and regulatory information
  • Must be able to adapt well to change
  • Must be able to present confidently
  • Must desire ownership

Nice to have

  • RAC certification
  • Familiarity with international medical device regulations for key markets (Health Canada, TGA Australia, ANVISA Brazil)
  • Experience with DFMEA and medical-grade risk management documentation
  • Exposure to or experience interfacing with FDA, Notified Bodies, or accredited test laboratories

What we offer

  • 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
  • company holidays
  • parental leave
  • identity theft protection
  • pet insurance
  • pre-paid legal insurance
  • back-up child and eldercare days
  • product discounts
  • referral bonus program
  • competitive health insurance
  • retirement plans
  • paid time off
  • employee stock purchase options
  • wellness programs
  • SharkNinja product discounts
  • Learning Programs
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