Principal Software Development Engineer (Embedded)

C & L Hospitality Group, Inc.; Andover (MA); On-site; USD 152,000 - 216,000; Full time

Job summary

TransMedics, Inc. seeks a Principal Software Engineer (Embedded) to drive embedded software across the Organ Care System portfolio. You will design, implement, and validate critical medical device software in a regulated environment.

You will lead core development activities, collaborate with cross-functional teams, and ensure rigorous testing, documentation, and traceability per FDA/IEC 62304 standards. HQ relocation planning to Somerville, MA supports innovation and growth.

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.
• Must be team-oriented with strong interpersonal and communication skills.

Responsibilities

• 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 (FDA/IEC 62304).
• Address field concerns by root-cause analysis and corrective actions.
• Support quality audits and FDA submissions.

Skills

Embedded software

C/C++

OO design / UML

Device driver development

RTOS (QNX)

Git / version control

JIRA

Ubuntu

LabVIEW

Education

BS/MS in Software Engineering or Electrical Engineering

Tools

Qt framework

CMake

JTAG

GNU tools

Momentics

USB OTG

Job description

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.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.RESPONSIBILITIESThis position is responsible for, but not limited to, the following:Work with stakeholders to determine software requirements and develop risk analysis for new applicationsDesign, implement, unit test, and document embedded softwareWrite and execute software unit and system test plans and proceduresManage software development projects through the full product lifecycleDevelop and maintain software development procedures per regulatory standards, e.g., FDA guidance, IEC 62304Manage procedures and deliverables for software verificationAddress field complaints by determining root cause and implementing corrective actionsSupport quality audits and the development of FDA submissionsPerform other TransMedics tasks and duties as assigned/required.MANAGEMENT RESPONSIBILITIESThis position manages the following positions on a daily basis.This position will not have management responsibilities.PHYSICAL ATTRIBUTESGeneral Office EnvironmentAbility to lift up to 25 lbs.May travel up to 10% domestically / 10% internationallyMINIMUM QUALIFICATIONSBS/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 QUALIFICATIONSEmbedded 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.comTransMedics 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 MADentalVisionHealthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet insuranceEmployee Stock Purchase PlanTransMedics 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.