Design Quality Engineer - FULLY REMOTE

The Design Quality Engineer plays a central role in ensuring the safety, reliability, and regulatory compliance of new and existing medical device products. This position focuses on ISO-compliant risk management throughout the entire product lifecycle and requires close collaboration with R&D, Regulatory Affairs, Manufacturing, and Quality Systems teams. The role is ideal for an engineer with strong analytical skills, a deep understanding of design controls, and hands‑on experience guiding engineering teams through risk‑based decision‑making for medical devices.

• Lead the development, execution, and maintenance of comprehensive risk management files in accordance with ISO standards, including hazard analysis, FMEA, fault tree analysis, and benefit risk assessments.

• Support design control activities in alignment with QSR/21 CFR 820.30, ensuring risk management is fully integrated into design planning, design inputs and outputs, verification, validation, and design transfer.

• Collaborate with cross‑functional teams to identify potential hazards, evaluate associated risks, and implement effective risk controls for medical device designs.

• Review and approve design documentation, engineering changes, and technical files to ensure compliance with internal procedures and applicable regulatory requirements.

• Participate in design reviews, providing expert guidance on risk mitigation strategies, usability considerations, and overall design robustness.

• Ensure clear traceability between design inputs, risk controls, verification and validation activities, and final product requirements.

• Support regulatory submissions by preparing and reviewing risk management documentation that demonstrates compliance and sound risk‑based decision‑making.

• Contribute to post‑market surveillance activities, including complaint analysis, CAPA investigations, and updates to risk management files based on field performance and feedback.

• Drive continuous improvement of risk management processes, tools, and templates to enhance efficiency, consistency, and regulatory alignment.

• Provide training and mentorship to engineering and cross‑functional teams on risk management best practices, tools, and methodologies.

• Bachelors degree in Engineering, such as Mechanical, Biomedical, Electrical, or a closely related field.

• 35 years of experience in medical device design quality, design assurance, or risk management.

• Strong working knowledge of ISO‑based risk management standards and QSR/21 CFR Part 820 requirements for medical devices.

• Hands‑on experience creating and maintaining risk management files for Class I, II, or III medical devices.

• Proficiency with risk analysis tools, including DFMEA, PFMEA, fault tree analysis (FTA), and hazard analysis.

• Experience supporting design controls and product development processes within a regulated medical device environment.

• Excellent written and verbal communication skills, with the ability to influence and guide engineering teams and cross‑functional stakeholders.

• Strong analytical and problem‑solving abilities, with a structured and detail‑oriented approach to risk assessment and mitigation.

• Experience participating in or supporting Notified Body audits or FDA inspections related to medical device products.

• Risk management certification, such as ISO lead auditor or lead implementer, is a plus.

• backgrnd in medical device quality engineering and quality systems is beneficial.

• Demonstrated ability to drive continuous improvement initiatives in risk management processes and tools.

• Experience providing training or mentorship on risk management practices within engineering or quality teams.