Senior Software Engineer

Job Description

Position: Senior Software Engineer

Report to: Director of Software Development

TransMedics, Inc. is a medical technology company that is transforming solid organ transplantation for patients with end-stage heart, lung, and liver failure. The Organ Care System (OCS), a first-in-class proprietary device/solution platform, was developed to improve quality, validate viability, and increase the utilization of donor organs for transplantation. TransMedics OCS Heart, OCS Lung, and OCS Liver systems currently have both U.S. PMA approvals and are CE-Marked. TransMedics is the undisputed global leader in organ transplantation in a new multi-billion-dollar medical device industry.

We are currently seeking a talented and driven Senior Software Engineer to join our team. Reporting to the Director of Software Development, the Senior Software 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.

Essential Job Responsibilities And Duties Include:

1. Work with stakeholders to determine software requirements and develop risk analysis for new applications.
2. Design, implement, unit test, and document embedded software.
3. Write and execute software unit and system test plans and procedures.
4. Develop and maintain software development procedures per regulatory standards, e.g., FDA guidance, IEC 62304.
5. Manage procedures and deliverables for software verification.
6. Address field complaints by determining root cause and implementing corrective actions.
7. Support quality audits and the development of FDA submissions.
8. Perform other TransMedics tasks and duties as required.

Requirements:

1. BS/MS in Software Engineering, Electrical Engineering, or equivalent.
2. 8+ years of related experience in real-time embedded software development in a Class II or Class III FDA regulated environment.
3. Proficient in C and C++.
4. Device driver level development (e.g., UART, I2C, SPI, ADC, BT, USB OTG) preferred.
5. ARM Processor and PIC microcontroller development preferred.
6. Experience with RTOS (e.g., QNX RTOS or equivalent).
7. Standard embedded development and debug tools (e.g., GNU, Momentics, JTAG).
8. Standard Configuration Management and Project Tools (e.g., Git, JIRA, Scripts, Labview).
9. Familiarity with CI/CD build environment infrastructure.
10. Integration of testing, static analysis, and security frameworks, a plus.
11. Must be team-oriented with outstanding interpersonal and communication skills (written and verbal).
12. Must be detail-oriented and highly organized.