Design Quality Engineer: Medical Devices & Risk Management

Actalent; Fremont (CA); Remote; USD 83,000 - 92,000; Part time

Job summary

Actalent is seeking a Design Quality Engineer to lead ISO-based risk management for medical devices across the lifecycle. The role collaborates with R&D, Regulatory Affairs, Manufacturing, and Quality Systems to ensure design controls align with QSR/21 CFR 820.30 and to maintain robust risk documentation.

Based in Fremont, CA, this contract position offers exposure to hazard analysis, FMEA, and post-market surveillance, with opportunities to mentor teams and drive continuous improvement in risk

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or 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.

Responsibilities

• 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.

Skills

ISO risk management

FMEA

PFMEA

FTA

Hazard analysis

Design controls

Regulatory awareness

Cross-functional

Documentation

Communication

Education

Bachelors in Engineering

Tools

DFMEA

PFMEA

FTA

Hazard analysis

Job description

Actalent is seeking a Design Quality Engineer to lead ISO-based risk management for medical devices across the lifecycle. The role collaborates with R&D, Regulatory Affairs, Manufacturing, and Quality Systems to ensure design controls align with QSR/21 CFR 820.30 and to maintain robust risk documentation.

Based in Fremont, CA, this contract position offers exposure to hazard analysis, FMEA, and post-market surveillance, with opportunities to mentor teams and drive continuous improvement in risk