Principal Software Development Engineer (Embedded)

TransMedics, Inc.; United States; On-site; USD 152,000 - 216,000; Full time

Benefits offered by this job

Bonuses

Equity

Healthcare benefits

Job summary

TransMedics, Inc. is seeking a Principal Software Engineer (Embedded) to contribute to the full lifecycle of embedded software for the Organ Care System (OCS).

The role focuses on designing, implementing, and validating software that preserves donor organs, adhering to FDA guidance and IEC 62304, with onsite work five days a week. With 10+ years in real-time embedded development, you will collaborate with stakeholders, drive verification efforts, and support FDA submissions while ensuring

Qualifications

• BS/MS in Software Engineering, Electrical Engineering, or equivalent.
• 10+ years of real-time embedded software experience.

Responsibilities

• Determine software requirements and perform risk analysis for new applications.
• Design, implement, validate embedded software and document it.

Skills

Embedded software

Risk analysis

Unit testing

Software lifecycle

Regulatory standards

Education

BS/MS in Software or Electrical Engineering

Tools

C/C++

Qt framework

RTOS (QNX)

Git/JIRA

Job description

Job Description:

POSITION SUMMARY

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.

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 complaintsby 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 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, 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 $151,500.00 - $215,700.00 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.