TransMedics
Job Description:
POSITION SUMMARY
We are seeking a highly experienced and technically versatile Principal Systems Engineer with a strong foundation in electrical engineering, complemented by working knowledge of chemistry or biosensing principles. This senior-level role is critical to leading the integration of complicated electromechanical subsystems and biosensors into our organ preservation systems and acting as a strategic liaison with external development partners and internal cross-functional teams. As the Principal Systems Engineer, you will provide technical leadership, drive architecture decisions, and ensure system-level cohesion across electrical, fluidic, biochemical, and software interfaces. You will also mentor junior engineers, lead technical risk management efforts, and contribute to long-term product strategy.
RESPONSIBILITIES
This position is responsible for, but not limited to, the following: Act as lead technical liaison with sensor development firms and cross-functional stakeholders Provide senior-level guidance on systems architecture and design trade-offs Serve as technical owner and systems integrator for all subsystems and biosensors within our product ecosystem Interface with and manage external design and development firms, ensuring adherence to timelines, specifications, and quality standards Translate clinical and functional requirements into system-level architecture and testable specifications Lead design reviews, risk assessments, and integration planning across electrical, mechanical, software and fluidic, and biochemical subsystems Coordinate V&V (verification and validation) activities related to subsystem and sensor performance and system compatibility Ensure compliance with applicable regulatory standards (e.g., ISO 13485, IEC 60601, FDA guidance) Collaborate with internal R&D, software, clinical, and regulatory teams to advance product development milestones 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
Office Environment Ability to lift 25 pounds MINIMUM QUALIFICATIONS
Bachelor's degree in Electrical Engineering or equivalent technical field 8+ years of experience in medical device or diagnostics development, with increasing responsibility PREFERRED QUALIFICATIONS
Masters degree in either Electrical, Computer or Biomedical Engineering Proven experience in biosensor systems monitoring applications Demonstrated ability to oversee external development teams or OEM suppliers Familiarity with system architecture, signal processing, and device integration Experience with design control processes and medical product lifecycle development Working knowledge of biocompatibility, fluid dynamics, or clinical workflows is a plus Strong systems thinking across hardware, software, and biology Effective communicator and technical project coordinator Detail-oriented with a high sense of ownership Comfortable working in early-stage, cross-functional teams Adaptable and hands-on, with the ability to shift between technical depth and high-level coordination Experience managing or guiding cross-functional engineering teams Proven track record of technical leadership and systems integration in regulated medical products
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 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.
POSITION SUMMARY
We are seeking a highly experienced and technically versatile Principal Systems Engineer with a strong foundation in electrical engineering, complemented by working knowledge of chemistry or biosensing principles. This senior-level role is critical to leading the integration of complicated electromechanical subsystems and biosensors into our organ preservation systems and acting as a strategic liaison with external development partners and internal cross-functional teams. As the Principal Systems Engineer, you will provide technical leadership, drive architecture decisions, and ensure system-level cohesion across electrical, fluidic, biochemical, and software interfaces. You will also mentor junior engineers, lead technical risk management efforts, and contribute to long-term product strategy.
RESPONSIBILITIES
This position is responsible for, but not limited to, the following: Act as lead technical liaison with sensor development firms and cross-functional stakeholders Provide senior-level guidance on systems architecture and design trade-offs Serve as technical owner and systems integrator for all subsystems and biosensors within our product ecosystem Interface with and manage external design and development firms, ensuring adherence to timelines, specifications, and quality standards Translate clinical and functional requirements into system-level architecture and testable specifications Lead design reviews, risk assessments, and integration planning across electrical, mechanical, software and fluidic, and biochemical subsystems Coordinate V&V (verification and validation) activities related to subsystem and sensor performance and system compatibility Ensure compliance with applicable regulatory standards (e.g., ISO 13485, IEC 60601, FDA guidance) Collaborate with internal R&D, software, clinical, and regulatory teams to advance product development milestones 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
Office Environment Ability to lift 25 pounds MINIMUM QUALIFICATIONS
Bachelor's degree in Electrical Engineering or equivalent technical field 8+ years of experience in medical device or diagnostics development, with increasing responsibility PREFERRED QUALIFICATIONS
Masters degree in either Electrical, Computer or Biomedical Engineering Proven experience in biosensor systems monitoring applications Demonstrated ability to oversee external development teams or OEM suppliers Familiarity with system architecture, signal processing, and device integration Experience with design control processes and medical product lifecycle development Working knowledge of biocompatibility, fluid dynamics, or clinical workflows is a plus Strong systems thinking across hardware, software, and biology Effective communicator and technical project coordinator Detail-oriented with a high sense of ownership Comfortable working in early-stage, cross-functional teams Adaptable and hands-on, with the ability to shift between technical depth and high-level coordination Experience managing or guiding cross-functional engineering teams Proven track record of technical leadership and systems integration in regulated medical products
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 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.