Senior Product Safety and Compliance Engineer- Medical Devices

SharkNinja is a global product design and technology company known for its innovative lifestyle solutions. The Senior Product Safety & Compliance Engineer will collaborate with product developers and certification partners to ensure regulatory compliance for medical devices, leading certification projects from concept to production.

Responsibilities:

• Assist in owning 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
• Support the preparation of 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
• Establish project needs and deliverables for both our 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, including hazard identification, risk estimation, risk evaluation, and residual risk documentation across the product lifecycle
• Support usability engineering processes per IEC 62366-1, including participation in formative and summative evaluation planning for medical device products intended for home healthcare environments
• Continuously evaluate project risk during the development process and establish contingency plans to overcome obstacles, including regulatory strategy adjustments driven by classification questions or design changes
• Lead weekly reviews for all assigned projects, presenting status and associated project risks including certification timelines and Notified Body or FDA feedback cycles
• Assure that all activities related to product certification commence and execute as planned and on schedule, with attention to FDA review timelines and CE marking milestones under EU MDR
• Support product development teams as a subject matter expert, providing counsel on medical device-specific requirements including biocompatibility (ISO 10993 series), software lifecycle (IEC 62304), and home healthcare electrical safety (IEC 60601-1-11)
• Assist in leading intradepartmental continuous improvement and special projects, including contribution to post-market surveillance and complaint handling processes under 21 CFR Part 803 and EU MDR
• Provide leadership and mentoring to junior team members on both consumer product certification and medical device regulatory frameworks

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 5+ years of compliance or design-related experience with consumer, commercial, or medical electromechanical products
• Strong 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)
• Experience interfacing with FDA, Notified Bodies, or accredited test laboratories preferred