Senior Software Test Engineer, Lead

TransMedics•Andover, MA

19h•Onsite

About The Position

TransMedics, Inc. is a commercial-stage medical technology company dedicated to transforming organ transplant therapy globally. Their core mission is to enhance patient lives by expanding access to viable donor organs for those awaiting transplantation. The company achieves this by collaborating with transplant stakeholders worldwide, providing high-quality technology, service, clinical care, and improved outcomes. Driven by a commitment to patient care, TransMedics strives to make the impossible possible and values its employees. The company aims to improve the quality of life for transplant recipients and their families, fostering hope and healing. As part of its long-term growth strategy, TransMedics plans to relocate its headquarters to Somerville, MA by 2028, establishing a state-of-the-art facility designed to promote collaboration, creativity, and discovery. The Senior Software Test Engineer, Lead will play a crucial role in the lifecycle of digital clinical software applications used to preserve donated hearts, lungs, livers, and other organs on the OCS. Please note that this position does not offer visa sponsorship, and TransMedics cannot take over existing employment visa sponsorships.

Requirements

BS/MS in Computer Science, Engineering, or equivalent combination of education and experience.
8+ years of related experience in a full-stack software testing.
At least 1 year on verifying Software as a Medical Device (SaMD).
Must be team-oriented with outstanding interpersonal and communication skills (written and verbal).
Must be detail-oriented and highly organized.

Nice To Haves

Experience in writing full-stack software test plans and test procedures.
Experience in executing full-stack software tests and generating reports.
Experience in developing automated software tests using test automation tools.
Experience in testing iOS-based mobile apps and AWS cloud applications.
Familiarity or experience in XCUITest and Appium.
Knowledge of regulatory and technical requirements for SaMD development, including quality management systems (ISO 13485) and risk management (ISO 14971).
Knowledge of infrastructure-as-code (e.g., AWS CloudFormation, Terraform, AWS SAM), CI/CD pipelines, and DevOps best practices.
Knowledge of the full software development lifecycle in a regulated environment.
Medical device software testing experience with compliance to IEC-62304, IEC-82304, and FDA guidelines is a plus.

Responsibilities

Lead test engineering activities for new development projects.
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 and digital software developers, 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.
Write verification and validation protocols based upon requirements and user needs.
Perform other TransMedics tasks and duties as assigned/required.

Benefits

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
Dental
Vision
Healthcare Flexible Spending Account
Dependent Care Flexible Spending Account
Short Term Disability
Long Term Disability
401K Plan
Pet insurance
Employee Stock Purchase Plan
bonuses
equity
comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources)