Principal Software Test Engineer (Embedded), Lead

TransMedics, Inc.•Andover, MA

About The Position

We are currently seeking a talented and driven Principal Software Test Engineer (Embedded), Lead to join our team. The Principal Software Test Engineer will have the opportunity to contribute to the life cycle of embedded software applications that preserve donated hearts, lungs, livers, and other organs on the OCS.

Requirements

BS/MS in Software Engineering, Electrical Engineering, or equivalent combination of education and experience.
10+ years of related experience in real-time embedded software testing.

Nice To Haves

Experience in planning, managing, and executing software testing activities.
Experience in writing software test procedures and conducting software system level testing.
Strong knowledge of software in a hardware testing methodology.
Experience in an FDA-regulated Class II and/or Class III medical device testing.
Experience with embedded systems and integration testing with external systems.
Testing experience with Bluetooth/BLE and Cloud-connected devices preferred.
Software integration testing and test automation experience is a plus.
Experience with requirements and test case management tools.
Experience with defect management tools.
Experience in an agile development environment is preferred.
Medical device software testing experience with compliance to IEC-62304 and FDA guidelines.

Responsibilities

Lead the development and execution of manual and automated software test activities
Define test strategy, test plans, and test protocols for medical device embedded software, ensuring compliance with regulatory requirements
Collaborate with embedded software, hardware, and systems engineers to identify testing requirements and troubleshooting issues.
Manage requirements and ensure traceability to all protocols and specifications
Design and validate new test methods, software test tools and test fixtures
Release all test protocol and fixture documentation using change order process
Execute Software V&V test protocols and write verification and validation reports
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.