Senior Product Safety and Compliance Engineer- Medical Devices

Position Overview

The Senior Product Safety & Compliance Engineer will partner with global product developers and certification partners to manage all aspects of regulatory compliance and product certification. The role leads multiple certification projects from product concept to mass production, ensuring market access requirements are met and product designs employ appropriate risk mitigation solutions. Active participation in medical device regulatory pathways alongside consumer and commercial product portfolios is required.

• Own 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 preparation of regulatory filings such as FDA 510(k) submissions and technical files/descriptive packages, 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 product development teams and third‑party regulatory partners, including Notified Bodies and FDA‑accredited testing laboratories.
• Execute risk management activities per ISO 14971, documenting hazard identification, risk estimation, risk evaluation, and residual risk across the product lifecycle.
• Support usability engineering 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 development, creating 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 risks, certification timelines, and Notified Body or FDA feedback cycles.
• Ensure all product certification activities commence and execute as scheduled, respecting FDA review timelines and CE marking milestones under EU MDR.
• Provide subject‑matter expertise to product development teams on medical device‑specific requirements, including biocompatibility (ISO 10993 series), software lifecycle (IEC 62304), and home healthcare electrical safety (IEC 60601‑1‑11).
• Support intradepartmental continuous improvement and special projects, contributing to post‑market surveillance and complaint handling under 21 CFR Part 803 and EU MDR.
• Provide leadership and mentoring to junior team members on consumer product certification and medical device regulatory frameworks.

• 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.
• Relevant discipline background:
  Biomedical/Bioengineering for ISO 10993 biocompatibility and clinical evaluation;
  Systems Engineering for ISO 14971 risk management and design controls;
  Chemical/Materials Engineering for material selection, substance compliance (REACH, RoHS), and biocompatibility testing;
  Computer Science/Software Engineering for IEC 62304 software lifecycle and embedded systems compliance.
• 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 (e.g., 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…