Senior Design Quality Engineer
TransMedics, Inc.
Summary
The Senior Design Quality Engineer plays a critical role in ensuring medical devices meet safety, effectiveness, regulatory compliance, and business requirements throughout the design and development process. Reporting into the Quality Department, this role collaborates with cross-functional teams supporting New Product Development and Sustaining Engineering projects for complex electromechanical medical devices, with a key focus on Software (embedded and standalone).
Job description
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 Standard Operating Procedures (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
Requirements
- Bachelor's degree in Engineering or other scientific or related field
- 8+ years experience in medical device or relevant regulated industry
- Strong knowledge of design control, risk management, and regulatory requirements (FDA, EU MDR, ISO 13485, ISO 14971)
- Working knowledge of design development and application of risk management
- Medical device software development and/or testing experience with compliance to 62304 and FDA guidelines
- Ability to organize and prioritize workflow across multiple projects
- Excellent organizational and interpersonal skills working in a cross-functional team
- Excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility
Benefits
- Medical, Dental & Vision
- Healthcare Flexible Spending Account
- Dependent Care Flexible Spending Account
- Short & Long Term Disability
- 401(k) Plan
- Pet Insurance
- Employee Stock Purchase Plan
- Paid Time Off
- Wellness Resources
Company overview
TransMedics, Inc. is a commercial-stage medical technology company revolutionizing organ transplant therapy for patients worldwide. Founded in 1998 and headquartered in Andover, Massachusetts, the company has developed the innovative Organ Care System (OCS™) technology platform that transforms organ preservation from static cold storage to dynamic perfusion systems. The OCS is the only FDA-approved technology for lung, heart, and liver transplant indications in the United States, enabling the optimization and assessment of donor organs outside the human body. This groundbreaking technology replicates near-physiologic conditions where the lung breathes, the heart beats, and the liver produces bile while being transported. TransMedics operates the National OCS Program (NOP), featuring a nationwide team of clinical experts, 24/7 logistics support, and a dedicated air and ground transport network. The company's mission focuses on increasing access to viable donor organs for transplant patients, addressing the critical shortage of transplantable organs. With over 25 years of commitment to innovation, TransMedics has established itself as a leader in advancing the field of organ transplantation through its comprehensive technology platform and clinical expertise.