Verification Engineer – Medical Devices

Verification Engineer – Medical Devices

Location:

Concord, California

We are seeking a highly motivated Verification Engineer with experience in medical device testing and regulatory documentation. The candidate will play a key role in executing verification and validation (V&V) activities, supporting 510(k) submissions, and ensuring compliance with FDA and IEC standards. This role requires strong technical expertise in testing medical products, preparing documentation for regulatory approval, and collaborating with cross-functional teams to deliver safe and effective medical devices.

Key Responsibilities:

• Plan, develop, and execute verification and validation (V&V) protocols for medical devices in compliance with FDA and IEC standards.
• Perform medical product testing at FMC (Fresenius Medical Care or relevant medical facility) to ensure functionality, safety, and reliability.
• Prepare and maintain documentation for 510(k) submissions, including verification reports, test protocols, and traceability matrices.
• Support regulatory and quality teams in preparing documentation for audits and regulatory filings.
• Review and interpret product requirements and translate them into effective test cases.
• Collaborate with R&D, Quality Assurance, and Regulatory Affairs to ensure product compliance with global standards.
• Analyze test results, document findings, and support root cause investigations for product issues.
• Ensure test activities meet requirements for ISO 13485, IEC 60601, and FDA 21 CFR Part 11 compliance.
• Contribute to continuous improvement initiatives in testing processes, tools, and documentation practices.

Required Skills &

Qualifications:

• Bachelor's degree in Biomedical Engineering, Electrical/Electronics, Mechanical, or related field.
• 3–5 years of experience in medical device verification and validation.
• Hands-on experience in medical product testing (electrical, mechanical, or software-based devices).
• Strong knowledge of FDA regulations, 510(k) submission requirements, and IEC/ISO medical device standards.
• Experience preparing verification protocols, test reports, and regulatory documentation.
• Familiarity with traceability matrices and requirements management tools (e.g., DOORS, Jama, Polarion).
• Strong analytical and problem-solving skills with attention to detail.
• Excellent written and verbal communication skills for documentation and cross-functional collaboration.

Preferred Qualifications:

• Experience in dialysis systems, infusion pumps, or other Class II/III medical devices.
• Knowledge of risk management (ISO 14971) and software validation (IEC 62304).
• Previous experience supporting FDA audits or regulatory inspections.
• Understanding of Good Documentation Practices (GDP) and Design Control requirements.