Quality Systems Engineer Jobs

Job Description:

TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport. Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide. The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.

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.

MINIMUM QUALIFICATIONS

• RESPONSIBILITIESThis position is responsible for, but not limited to, the following:§ 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 reportable 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.
• Identify trends, recurring failure modes, or systemic risks and escalate through CAPA or other quality processes when warranted.
• 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

PREFERRED 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.
• Experience analyzing mechanical and/or electromechanical systems preferred.
• 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.

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is 118,300 - $148,000 which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

EQUAL EMPLOYMENT OPPORTUNITY

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability, protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.