Design Quality Engineer III
Role details
Job location
Tech stack
Job description
- Lead the development, execution, and maintenance of risk management files in accordance with ISO standards, including hazard analysis, FMEA, fault tree analysis, and benefit-risk assessments.
- Support design control activities per 21 CFR 820.30, ensuring risk management is fully integrated into design planning, verification, validation, and design transfer.
- Collaborate with cross-functional teams to identify potential hazards, evaluate risks, and implement effective risk controls.
- Review and approve design documentation, engineering changes, and technical files for compliance with internal procedures and regulatory requirements.
- Participate in design reviews, providing expert guidance on risk mitigation strategies and usability considerations.
- Ensure traceability between design inputs, risk controls, verification/validation activities, and product requirements.
- Support regulatory submissions by preparing and reviewing risk management documentation.
- Contribute to post-market surveillance activities, including complaint analysis, CAPA investigations, and risk file updates.
- Drive continuous improvement of risk management processes, tools, and templates.
- Provide training and mentorship to engineering teams on risk management best practices.
Requirements
The Design Quality Engineer will play a central role in ensuring the safety, reliability, and regulatory compliance of new and existing medical device products. This position focuses heavily on ISO-compliant risk management throughout the product lifecycle, partnering closely with R&D, Regulatory Affairs, Manufacturing, and Quality Systems teams. The ideal candidate brings strong analytical skills, deep understanding of design controls, and hands-on experience guiding engineering teams through risk-based decision-making., * Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
- 5-7+ years of experience in medical device design quality, design assurance, or risk management.
- Strong working knowledge of ISO standards and 21 CFR Part 820.
- Hands-on experience creating and maintaining risk management files for Class I, II, or III medical devices.
- Proficiency with risk analysis tools (e.g., DFMEA, PFMEA, FTA, hazard analysis).
- Experience supporting design controls and product development processes.
- Excellent communication skills and the ability to influence engineering teams.
- Strong analytical and problem-solving abilities.
Additional Skills & Qualifications
- Experience with Notified Body audits or FDA inspections.
- Risk management certification (e.g., ISO lead auditor/lead implementer) is a plus.
Benefits & conditions
The position offers 3 weeks of PTO and 10 paid holidays. The work environment fosters collaboration among R&D, Regulatory Affairs, Manufacturing, and Quality Systems teams. The role involves working closely with engineering teams and requires adherence to dress codes pertinent to a professional and regulated industry setting.
Job Type & Location
This is a Contract position based out of Irvine, CA.
Pay and Benefits
The pay range for this position is $55.00 - $65.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type