Staff Risk Management Engineer – Quality

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the technical leader and subject matter expert for risk management throughout the medical device lifecycle.

• Ensure adherence to ISO 14971, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and various global regulatory standards.

• Lead the planning, execution, maintenance, and continuous enhancement of product risk management initiatives.

• Serve as the Quality Lead accountable for Risk Management Files for all existing products in the market.

• Collaborate with product core teams to ensure Risk Management Files are consistently updated.

• Own and draft risk analyses and risk management documentation, which includes hazard identification, risk evaluation, risk controls, and assessments of residual risks.

• Conduct and oversee complex gap assessments.

• Plan, organize, execute, and report on risk management activities and remediation efforts.

• Assist with Health Hazard Evaluations as part of the post-market surveillance process.

• Champion risk management and convey critical risk recommendations to cross-functional stakeholders.

• Work alongside Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance teams.

⛳️ Requirements

• Bachelor’s degree in a technical field with 8–12 years of relevant experience, or a Master’s degree with 5–7 years of equivalent industry experience, or a PhD with 2–4 years of experience.

• Extensive knowledge of ISO 14971:2019 and EU MDR (2017/745) risk requirements.

• Strong comprehension of FDA Quality System Regulations (21 CFR Part 820 and 860) and ISO 13485.

• Thorough understanding of industry best practices and emerging trends related to risk management processes, tools, and technologies.

• Solid working knowledge of verification and validation requirements within the medical device sector.

• Familiarity with requirements analysis, including the creation of testable and measurable specifications.

• Preferred knowledge of design controls, post-market surveillance, and root cause failure analysis.

• Travel is required: 5–15%.

🏝️ Benefits

• Comprehensive and inclusive benefits program.

• Opportunities for growth on a global scale.

• Career development through internal learning initiatives and/or eligible tuition reimbursement.

• Work in an innovative, industry-leading organization dedicated to employees, customers, and communities.