Senior Quality Systems Engineer, Medical Devices

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

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.