Senior Test Engineer

POSITION SUMMARY 

We are seeking a results-driven Senior Test Engineer with experience in the medical device industry to join our test engineering team. This role is responsible for developing, executing, and overseeing the testing strategies that ensure the safety, reliability, and compliance of Class II/III medical devices in Accordance with FDA and ISO 13485 regulations.

The ideal candidate has a deep understanding of medical device lifecycle processes and a strong technical background in test systems, automation, and compliance in regulated environments. 

This position is based at our Andover, MA headquarters.  

RESPONSIBILITIES 

This position is responsible for, but not limited to, the following: 

• Lead test engineering activities for new development projects.  
• Responsible for conducting feasibility and verifications testing including system, environmental, usability, biocompatibility, reliability, sterility, and safety testing.  
• Manage requirements and ensure traceability to all protocols and specifications.  
• Write verification and validation protocols based upon requirements and user needs.  
• Design and validate new test methods and test fixtures.  
• Release all test protocol and fixture documentation using change order process.  
• Test prototypes using laboratory equipment and document in DHF.  
• Execute V&V test protocols and write verification and validation reports.  
• Fabricate prototypes with assistance from technical support team (Machine Shop, Technicians and Designers) and suppliers.  
• Assist in software test validation, FMEAs, and Design Reviews.   
• Maintain test equipment to ensure calibration and preventative maintenance are performed.  
• Coordinate test activities with external testing partners.  
• Perform other TransMedics tasks and duties as assigned/required.  

MANAGEMENT RESPONSIBILITIES 

This position manages the following positions on a daily basis. 

• This position will not have management responsibilities. 

 PHYSICAL ATTRIBUTES  

• Onsite 5 days per week
• Ability to lift 25lbs.   

MINIMUM QUALIFICATIONS  

• BS in Mechanical, Electrical or Biomedical Engineering  
• At least 8 years of experience in a regulated environment

PREFERRED QUALIFICATIONS 

• 2 years in a lead role for performing verification and validation testing on Class II or III medical devices.  
• Strong understanding of medical device development processes including experience with FDA CFR 820 and ISO 13485 regulations  
• Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency.  
• Strong problem-solving skills with the ability to identify root cause for test failure.  
• Experience applying statistical techniques to determine sample sizes based on risk  
• Ability to work independently with high competency and little guidance  
• Strong written and verbal communication skills are required.  
• Ability to use laboratory equipment, hand and power tools
• Proficiency with Minitab and a Six Sigma Green Belt is strongly desired.  
• Basic knowledge using Solidworks 3D modeling is highly desired.  

As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary.

Every Organ Wasted is a Life Not Saved.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. 

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. 

Maximize your potential at TransMedics, Inc.

www.TransMedics.com 

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $118,600.00 – $148,000.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.