Principal Software Development Engineer; Embedded

Job Description:

POSITION SUMMARYWe 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.Trans Medics, 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. Trans Medics OCS Heart, OCS Lung, and OCS Liver systems currently have both U.S. PMA approvals and are CE-Marked. Trans Medics 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.

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

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

PREFERRED QUALIFICATIONS 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.

As part of our long-term growth plans, Trans Medics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients.

Specific timing and role impact may vary.

Every Organ Wasted is a Life Not Saved.

Trans Medics, 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…