Job description

Job Description: 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 Development Engineer to join our team. The Senior Software Development 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 ▪ 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. MINIMUM QUALIFICATIONS • BS/MS in Software Engineering, Electrical Engineering, or equivalent combination of education and experience. • 8 years of related experience in real-time embedded software development. • Proficient in C and C ; Qt framework, a plus. PREFERRED QUALIFICATIONS • 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) • 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, TransMedics 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. 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 TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $129,000.00 – $183,600.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history. 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. 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.

Requirements

Must-haves

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
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.
BS/MS in Software Engineering, Electrical Engineering, or equivalent combination of education and experience.
8 years of related experience in real-time embedded software development.
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA

Nice-to-haves

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)
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.

Application prep

Use the role’s language and application details while tailoring your materials.

Keywords to mirror

jiraci/cd

Platform: workday
Effort: long

Benefits

Benefits detected in the listing.

Dental

Vision

401k

Paid Time Off

Wellness