Senior Software Test Engineer, Lead

Senior Software Test Engineer, Lead

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

Responsibilities

This position is responsible for, but not limited to, the following:

• 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.

Management Responsibilities

This position manages the following positions on a daily basis.

• This position will not have management responsibilities.

Physical Attributes

• General Office Environment
• Ability to lift up to 25 lbs.
• May travel up to 10% domestically / 10% internationally

Minimum Qualifications

• 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).

Preferred Qualifications

• 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.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.

Maximize your potential at TransMedics, Inc.

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $147,200.00– $183,600.00, which represents the company's current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

Employee Benefit:

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVision Healthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet insurance Employee Stock Purchase Plan

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.