Senior Product Safety And Compliance Engineer- Medical Devices

Senior Product Safety and Compliance Engineer – Medical Devices

The Senior Product Safety and Compliance Engineer will partner with global product developers and certification partners to manage regulatory compliance and product certification projects from concept through mass production. The role involves medical device regulatory pathways and consumer product certification, ensuring market access requirements are met and risk mitigation solutions are integrated into designs.

• Own certification activities and risk analysis for new product development projects, including FDA-regulated medical devices and EU MDR 2017/745 products.
• Prepare regulatory filings such as FDA 510(k) submissions and Technical Files/Design Dossiers; maintain Design History Files (DHF) in compliance with 21 CFR Part 820 and ISO 13485.
• 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 processes per IEC 62366‑1, including formative and summative evaluation planning for medical device products intended for home healthcare environments.
• Continuously evaluate project risk and develop contingency plans to address obstacles, including regulatory strategy adjustments due to classification questions or design changes.
• Lead weekly project reviews, presenting status, risks, certification timelines, and feedback cycles from Notified Bodies or FDA.
• Ensure product certification activities commence and execute on schedule, meeting FDA review timelines and CE marking milestones under EU MDR.
• Provide subject‑matter expertise on medical device requirements such as biocompatibility (ISO 10993 series), software lifecycle (IEC 62304), and home healthcare electrical safety (IEC 60601‑1‑11).
• Lead intradepartmental continuous improvement and special projects, contributing to post‑market surveillance and complaint handling under 21 CFR Part 803 and EU MDR.
• Mentor 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 context:
  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, and biocompatibility testing;
  Computer Science/Software Engineering for IEC 62304 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 related collateral standards, ISO 14971, ISO 13485, IEC 62366‑1, IEC 62304, ISO 10993 series, 21 CFR Part 820, EU MDR 2017/745, FDA 510(k) submission processes, and familiarity with international medical device regulations for Health Canada, TGA Australia, ANVISA Brazil.
• Experience with DFMEA and medical‑grade risk management documentation (hazard analysis, risk control verification, residual risk justification).
• Preferred experience interfacing with FDA, Notified Bodies, or accredited test laboratories.

• Operate comfortably in a fast‑paced environment with shifting priorities across consumer and regulated‑device programs.
• Manage multiple projects simultaneously while maintaining continuous tracking of regulatory submission status and design change impact assessments.
• Present creative and technically sound solutions to complex problems, including regulatory pathway questions where classification is ambiguous.
• Analyze operations and promote continuous improvement initiatives within design control and post‑market surveillance frameworks.
• Communicate…