Senior Design Quality Engineer – Medical Devices & Software

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

Benefits offered by this job

Medical benefits

Dental

Vision

401K Plan

Stock Purchase Plan

Job summary

TransMedics, Inc. in Andover, MA, is seeking a Senior Design Quality Engineer to ensure medical devices meet safety, regulatory, and business requirements across design and development.

You will influence project decisions, lead design controls, risk analyses, and verification activities for complex electromechanical devices with software components. The role collaborates with engineering, regulatory, and manufacturing teams, focusing on embedded and standalone software.

Qualifications

• Bachelor’s degree in Engineering or other scientific 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 compliance to 62304 and FDA guidelines.
• Ability to organize and prioritize workflow across multiple projects.

Responsibilities

• Ensure design controls process for the projects meets applicable regulatory, corporate, and customer QMS requirements.
• Collaborate with cross‑functional teams including engineering, manufacturing, project managers, and regulatory.
• Support new product development and sustaining projects for complex electrical/mechanical systems with software and disposables, with a key focus on Software in a medical device and embedded Software.
• Provide quality input to product user needs, requirements, and specifications.
• Provide quality input to critical to quality specifications.
• Support development of engineering design documentation.
• Support design and process verification and validations activities such as protocols, test cases, reports and resolution of issues identified during testing.
• Support design reviews and development of the design history file.
• Drive overall risk management process, including System Risk Analyses, FMEAs, risk controls and verification of effectiveness.
• Provide quality input for Cybersecurity and Software Safety assessments.
• Support Design Transfer activities.
• Assist in preparation for regulatory submissions and provide support during audits and inspections.
• Apply sound, systemic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Provide quality input and evaluation for Test Method Validations and Software Tool Validations.
• Provide support during Corrective and Preventive Action (CAPA) activities and manage CAPAs when necessary.
• Drive enhancements and continuous improvements to SOPs.
• Improve knowledge of design controls, risk management, testing, statistics, and design verification / validation.
• Mentor and provide guidance to junior engineers.
• Perform other Quality Systems related duties as required.
• Perform other TransMedics tasks and duties as assigned/required.

Skills

Design controls

Risk management

Regulatory knowledge

Cross-functional collaboration

Software in medical devices

Education

Bachelor’s degree in Engineering or related field

Tools

62304 Compliance

Job description

TransMedics, Inc. in Andover, MA, is seeking a Senior Design Quality Engineer to ensure medical devices meet safety, regulatory, and business requirements across design and development.

You will influence project decisions, lead design controls, risk analyses, and verification activities for complex electromechanical devices with software components. The role collaborates with engineering, regulatory, and manufacturing teams, focusing on embedded and standalone software.