Senior Quality Systems Engineer

TransMedics, Inc.; Andover (MA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical with Health Reimbursement

Dental

Vision

401K Plan

Paid time off

Job summary

TransMedics, Inc. is seeking a Senior Quality Systems Engineer in Massachusetts to lead complex complaint investigations for Class III medical devices.

The role involves hands-on troubleshooting, data analysis, root-cause determination and documentation in line with FDA and international regulatory standards. The ideal candidate will have an engineering background, strong problem-solving skills, and proven ability to translate findings into clear investigation records.

Qualifications

• Bachelor’s or Master’s degree in mechanical, electrical, biomedical engineering or related field.
• 7+ years in medical device or regulated environment (quality/ manufacturing/ engineering).
• Strong knowledge of 21 CFR Part 820, MDR, ISO 13485 and QMS practices.
• Excellent analytical, problem‑solving and technical writing skills.

Responsibilities

• Lead complaint investigations from intake to closure, ensuring timeliness, technical accuracy and regulatory compliance.
• Perform hands-on troubleshooting and failure analysis of returned devices and components.
• Analyze DHRs, manufacturing, service, software logs and field data to support investigations.
• Apply structured RCA methods (5 Whys, Fishbone, fault tree) to identify root causes and contributing factors.
• Collaborate with Engineering, Manufacturing, Service, Clinical and Regulatory teams to validate conclusions.
• Document investigation rationale, methods, data analysis, conclusions and reportability determinations clearly.
• Identify containment needs and coordinate cross‑functional actions to mitigate risks.
• Elevate trends, recurring failures and systemic risks through CAPA and quality processes when warranted.
• Support MDR evaluation, vigilance and regulatory reporting per global requirements.
• Participate in internal/external audits and regulatory inspections with technical clarity.
• Maintain inspection-ready documentation compliant with 21 CFR Part 820 and ISO 13485.
• Stay current on product architecture, subsystems, and intended use.

Skills

Quality systems

Regulatory compliance

Root cause analysis

Technical writing

Problem solving

Education

Bachelor's degree in Mechanical/Electrical/Biomedical Eng

Master's degree in Mechanical/Electrical/Biomedical Eng

Job description

Job Description

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

• This 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 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 elevate 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 elevate potential systemic issues appropriately.
• Identify trends, recurring failure modes, or systemic risks and elevate 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

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.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.

Maximize your potential at TransMedics, Inc.

www.TransMedics.com

TransMedics is committed to equitable and transparent compensation. The expected rate for this role is $90,000 - $110,000 which represents the company's current good-faith estimate of compensation for this position. Actual hour rate will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. Hourly roles may also be eligible for overtime, shift differentials, incentive programs, and our 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.

Employee Benefit

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan

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.