Quality Systems Engineer II

TransMedics, Inc.•Andover, MA

1d•Onsite

About The Position

We are seeking a technically driven Quality Systems Engineer II to take ownership of hands-on complaint investigations for Class III medical devices. This role is responsible for 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 foundation, a methodical approach to problem-solving, and the ability to translate technical findings into clear, compliant investigation records.

Requirements

Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related scientific discipline.
1-3 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 2-4 years of relevant industry experience.
Foundational understanding of 21 CFR Part 820, 21 CFR Part 803 (MDR), and ISO 13485.
Strong analytical and troubleshooting skills with the ability to interpret technical data.
Experience analyzing mechanical and/or electromechanical systems preferred.
Demonstrated ability to write clear, concise, and technically sound documentation.
Detail-oriented with strong organizational and time management skills.

Nice To Haves

Internship or co-op experience in complaint handling, product investigation, manufacturing, or reliability engineering.
Exposure to risk management principles per ISO 14971.
Experience reviewing manufacturing records, device history records, or test data.
Familiarity with statistical analysis or trending tools.
Experience working with capital equipment or complex electromechanical medical devices.

Responsibilities

Independently manage assigned complaint investigations from intake through closure, ensuring timeliness, technical accuracy, and regulatory compliance.
Perform hands-on troubleshooting 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 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.
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 development or refinement of test methods, investigation protocols, and complaint handling procedures to improve technical rigor and efficiency.
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