Senior Design Quality Engineer - Medical Devices, Software

TransMedics, Inc.; Andover (MA); On-site; USD 93,000 - 133,000; Full time

Benefits offered by this job

Medical benefits

401K Plan

Employee Stock Purchase Plan

Job summary

TransMedics, Inc. designs and manufactures the Organ Care System (OCS) to preserve donor organs outside the body, enabling better transplant outcomes.

The Senior Design Quality Engineer will guide design controls and risk management for complex electromechanical medical devices with embedded software, working across engineering, regulatory, and manufacturing teams. Based in Andover, MA, this role emphasizes software safety, cybersecurity input, and regulatory submissions, while supporting CAPA

Qualifications

• Bachelor’s degree in Engineering or related field required.
• 8+ years experience in medical device or regulated industry.
• Strong knowledge of design control, risk management, and regulatory requirements (FDA, EU MDR, ISO 13485, ISO 14971).
• Medical device software development and/or testing experience with 62304 and FDA guidelines.
• Ability to organize and prioritize workflow across multiple projects.
• Excellent organizational and interpersonal skills in cross-functional teams.
• Excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility.

Responsibilities

• Ensure design controls process meets regulatory, corporate, and customer QMS requirements
• Collaborate with engineering, manufacturing, project managers, and regulatory teams
• Support new product development and sustaining projects for complex electromechanical systems with software
• Provide quality input to product user needs, requirements, and specifications
• Drive risk management including System FMEAs and verification of effectiveness
• Support design transfer and regulatory submissions

Skills

Design controls

Risk management

Regulatory compliance

Cross-functional collaboration

Project prioritization

Education

Bachelor’s degree in Engineering or related field

Tools

FDA 62304

ISO 13485

Job description

TransMedics, Inc. designs and manufactures the Organ Care System (OCS) to preserve donor organs outside the body, enabling better transplant outcomes.

The Senior Design Quality Engineer will guide design controls and risk management for complex electromechanical medical devices with embedded software, working across engineering, regulatory, and manufacturing teams. Based in Andover, MA, this role emphasizes software safety, cybersecurity input, and regulatory submissions, while supporting CAPA