Staff Risk Management Engineer – Quality

About This Opportunity

We are representing a confidential medical device organization in their search for a Staff Risk Management Engineer - Quality. This is a fully remote role based in the United States, offering the opportunity to serve as the technical leader and subject matter expert for risk management across the complete product lifecycle.

In this position, you will ensure compliance with ISO 14971, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and other global regulatory requirements. You'll work cross-functionally with engineering, clinical, regulatory affairs, quality, manufacturing, human factors, and post-market surveillance teams to integrate risk management into product development while ensuring patient safety and regulatory compliance.

Responsibilities

• Serve as the Quality Lead responsible for Risk Management Files for all on-market products, working with product core teams to ensure documentation remains current
• Act as Subject Matter Expert for all on-market Risk Management Files
• Own and author comprehensive risk analyses and standard risk management documentation, including hazard identification, risk evaluation, risk controls, and residual risk assessments
• Perform and manage complex gap assessments, planning, organizing, executing, and reporting on active risk management activities and remediation projects
• Support Health Hazard Evaluations (HHE) as a core component of the post-market surveillance loop
• Act as the principal advocate for risk management, using strong communication skills to assess documentation and convey critical risk recommendations to cross-functional stakeholders

What We're Looking For

Required Qualifications:

• Bachelor's degree in a technical discipline with 8-12 years of related experience, OR Master's degree with 5-7 years of experience, OR PhD with 2-4 years of experience
• Deep expertise in ISO 14971:2019 (Risk Management for Medical Devices) and EU MDR (2017/745) risk requirements
• Strong understanding of FDA Quality System Regulations (21 CFR Part 820 and 860) and ISO 13485
• In-depth knowledge of industry best practices and emerging trends in risk management processes, tools, and technologies
• Strong working knowledge of verification and validation requirements across the medical device industry
• Clear understanding of requirements analysis, including development of testable and measurable specifications
• Excellent communication skills with the ability to convey complex technical information to diverse stakeholders

Preferred Qualifications:

• Knowledge of design controls, post-market surveillance, and root cause failure analysis

Travel: 5-15%

How We Work With You

When you apply through Get A Job.ai, our talent team will review your qualifications and conduct an initial screening. If there's a strong match, we'll submit your profile to our client for consideration. Throughout the process, we'll serve as your advocate and main point of contact. Please do not contact the client directly—all communication should flow through our recruiting team to ensure the best experience for everyone involved.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices. We welcome applications from all qualified candidates regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability status, or veteran status.