Principal Software Development Engineer (Embedded)

TransMedics, Inc.•Andover, MA

1d•Onsite

About The Position

We are currently seeking a talented and driven Principal Software Engineer (Embedded) to join our team. The Principal Software Engineer will have the opportunity to contribute to the full life cycle of embedded software applications that preserve donated hearts, lungs, livers, and other organs on the OCS. 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. This position is onsite 5 days a week.

Requirements

BS/MS in Software Engineering, Electrical Engineering, or equivalent combination of education and experience.
10+ years of related experience in real-time embedded software development.

Nice To Haves

Embedded software architecture development.
Proficient in C and C++; Qt framework, a plus.
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, CMake, JTAG).
Standard Configuration Management and Project Tools (e.g., Git, JIRA, Ubuntu, Labview).
Familiarity with CI/CD build environment infrastructure.
Strong knowledge of Object-Oriented Design (OOD and Unified Modeling Language (UML)
Experience with closed loop control algorithms, a plus.
Integration of testing, static analysis, and security frameworks, a plus.
Medical device software development experience with compliance to IEC-62304 and FDA guidelines.
Must be team-oriented with outstanding interpersonal and communication skills (written and verbal).
Must be detail-oriented and highly organized.

Responsibilities

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
Manage software development projects through the full product lifecycle
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
Perform other TransMedics tasks and duties as assigned/required.