Senior Test Engineer

TransMedics•Andover, MA

1d•$118,600 - $148,000•Onsite

About The Position

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.

Requirements

BS in Mechanical, Electrical or Biomedical Engineering
At least 8 years of experience with 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 .
Ability to use laboratory equipment, hand and power tools.
Ability to be onsite 5 days per week and lift 25lbs.

Nice To Haves

Proficiency with Minitab and a Six Sigma Green Belt is strongly desired.
Basic knowledge using Solidworks 3D modeling is highly desired.

Responsibilities

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.