Senior Software Engineer

transmedics; Andover (MA); On-site; USD 129,000 - 184,000; Full time

Benefits offered by this job

Medical with HRA through Blue Cross/BS

Dental

Vision

Healthcare FSA

Job summary

TransMedics, Inc. is seeking a Senior Software Development Engineer to contribute to the full life cycle of embedded software applications that preserve donated organs on the Organ Care System (OCS). This role requires 8+ years in real-time embedded software, proficiency in C/C++, and experience with RTOS such as QNX.

Knowledge of device drivers and regulatory standards (IEC-62304, FDA) is preferred. You will collaborate with stakeholders to define requirements, design and test software, and

Qualifications

• 8+ years of real-time embedded software development.
• Proficient in C and C++; Qt framework, a plus.
• Device driver level development experience preferred.
• Experience with RTOS (QNX RTOS or equivalent).
• Medical device software development with IEC-62304 and FDA guidance experience.

Responsibilities

• Determine software requirements with stakeholders and perform risk analysis.
• 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 (FDA IEC 62304).
• Manage procedures and deliverables for software verification.
• Address field complaints by root cause analysis and corrective actions.
• Support quality audits and FDA submissions.

Skills

C/C++

Qt framework

Device driver development

RTOS (QNX)

Education

BS/MS in Software Engineering or Electrical Engineering

Tools

GNU

Momentics

CMake

JTAG

Git

JIRA

Ubuntu

LabVIEW

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 Acco