Senior Software Test Engineer, Lead
About The Position
TransMedics, Inc. is seeking a talented and driven Senior Software Test Engineer, Lead to contribute to the life cycle of digital clinical software applications that preserve donated hearts, lungs, livers, and other organs on the Organ Care System (OCS). This position is not available for visa sponsorship. TransMedics is a commercial-stage medical technology company focused on transforming organ transplant therapy globally. Their mission is to save more patients' lives by increasing access to viable donor organs through their innovative OCS technology, which replicates the organ's natural living environment outside the body. The company is planning to relocate its headquarters to Somerville, MA by 2028 to foster innovation and collaboration.
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, with at least 1 year on verifying Software as a Medical Device (SaMD).
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.
- Must be team-oriented with outstanding interpersonal and communication skills (written and verbal).
- Must be detail-oriented and highly organized.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
251-500 employees
