Senior Quality Systems Engineer

Position Summary

We are seeking a technically driven Senior Quality Systems Engineer to lead complex, hands-on complaint investigations for Class III medical devices. This role is responsible for leading and performing structured, technically sound investigations, including device troubleshooting, data analysis, root cause determination, and comprehensive documentation in compliance with FDA and international regulatory requirements. The ideal candidate will have a strong engineering background, a methodical approach to problem-solving, and the ability to translate technical findings into clear, compliant investigation records.

Responsibilities

• Independently lead complaint investigations from intake through closure, ensuring timeliness, technical accuracy, and regulatory compliance.
• Perform hands-on troubleshooting, evaluation and failure analysis of returned devices and components, including mechanical, electrical, and system-level evaluation as applicable.
• Analyze device history records (DHRs), manufacturing records, service records, software logs, and field data to support root cause investigations.
• Apply structured root cause analysis methodologies (e.g., 5 Whys, Fishbone, fault tree analysis) to identify failure modes, root cause conclusions and contributing factors.
• Partner cross-functionally with Engineering, Manufacturing, Service, Clinical, and Regulatory teams to gather technical inputs and validate investigation conclusions.
• Clearly document investigation rationale, test methods, data analysis, conclusions, and justification for reportability determinations.
• Identify conditions requiring immediate or broader containment and work cross-functionally to ensure appropriate actions are initiated to mitigate potential risk in a timely manner.
• Identify trends, recurring failure modes, or systemic risks and escalate through CAPA or other quality processes when warranted.
• Support evaluation of complaints for Medical Device Reporting (MDR), vigilance, and other regulatory reporting requirements under 21 CFR Part 803 and applicable global regulations.
• Assess risk implications using ISO 14971 principles and escalate potential systemic issues appropriately.
• Support internal audits, external audits, and regulatory inspections by providing technical expertise and clearly communicating investigation approaches, findings, conclusions, and associated follow-up actions.
• Maintain inspection-ready documentation in compliance with 21 CFR Part 820, ISO 13485, and internal procedures.
• Maintain working technical knowledge of company products, including system architecture, subsystems, and intended use.
• Perform other TransMedics tasks and duties as assigned/required.

Minimum Qualifications

• Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or related scientific discipline.
• 7+ years of experience in medical device, regulated industry, manufacturing engineering, quality engineering, or related technical role.
• Or Master's degree in Mechanical, Electrical, Biomedical Engineering, or related scientific discipline with 5+ years of relevant industry experience.
• Strong working knowledge of medical device quality system and complaint handling requirements, including 21 CFR Part 820, 21 CFR Part 803 (MDR), and ISO 13485.
• Strong analytical and problem-solving skills with demonstrated ability to evaluate complex information, identify failure mechanisms, and develop technically supported conclusions.
• Strong technical writing skills with demonstrated ability to clearly and concisely document investigation methods, objective evidence, technical rationale, root cause conclusions, and supporting justification.
• Detail-oriented with strong organizational and time management skills.

Preferred Qualifications

• Experience evaluating complaint data and investigation findings to identify trends, emerging failure modes, systemic issues, or potential broader field impact.
• Experience investigating complex electromechanical systems, medical capital equipment, or products incorporating mechanical, electrical, software, and disposable components.
• Experience supporting or contributing to CAPA investigations, containment activities, product risk assessments, field action evaluations, or other systemic quality investigations.
• Experience participating in FDA inspections, notified body audits, or other regulatory or quality system audits.
• Experience with statistical analysis, data trending or other tools used to evaluate post-market product performance.
• Experience working with capital equipment or complex electromechanical medical devices.
• Experience working in a biosafety environment (BSL-2) preferred.