Principal Software Development Engineer at TransMedics, Inc.

Andover, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Feb, 26

Salary

0.0

Posted On

30 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Embedded Software Development, C, C++, Qt Framework, Device Driver Development, ARM Processor Development, PIC Microcontroller Development, RTOS, Object-Oriented Design, Unified Modeling Language, Closed Loop Control Algorithms, Static Analysis, Security Frameworks, FDA Compliance, Interpersonal Skills, Communication Skills, Detail-Oriented

Industry

Medical Equipment Manufacturing

Description

Job Description: POSITION SUMMARY 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 Principal Software Engineer 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. 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 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 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. Every Organ Wasted is a Life Not Saved. 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. www.TransMedics.com #LI-Hybrid Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.

Responsibilities

The Principal Software Engineer will contribute to the full life cycle of embedded software applications for organ preservation. Responsibilities include determining software requirements, designing and implementing software, managing projects, and supporting quality audits.