Job Description:

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

Job Description:

POSITION SUMMARY

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

Senior Test Engineer

Senior Test Engineer

TransMedics

TransMedics

Benefits

TransMedics