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Senior Software Engineer

2 months ago

Andover MA United States TransMedics Full time
Job Description:

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:

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

REQUIREMENTS:

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

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.