Senior Director, R&D, Digital & AI

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 seeking an experienced and dynamic Chief Engineer to lead the R&D Product Development division of our organization. The ideal candidate will have a strong background in digital AI, medical technology, and healthcare, with deep expertise in both software and hardware R&D. This leadership position is designed for a seasoned professional with a proven track record of managing cross-functional teams to develop innovative products that meet regulatory standards, particularly within the FDA landscape. The Chief Engineer will report directly to the Chief Technology Officer (CTO) and be responsible for overseeing the complete product development lifecycle.

ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:

As the Chief Engineer, R&D, Digital and AI at TransMedics, you will be responsible for the strategy and development of our Next Generation Products.

Key responsibilities include:

• Lead R&D Initiatives: Take charge of the end-to-end product development process, ensuring both software and hardware components are effectively integrated and meet the highest standards of quality and safety.
• Digital & AI Expertise: Utilize your expertise in digital AI to drive innovation in product development, ensuring the integration of cutting-edge technologies to solve complex healthcare challenges.
• Cross-Functional Leadership: Manage a multidisciplinary team of engineers, designers, and researchers in the development of medical technology products. Collaborate closely with regulatory, clinical, and marketing teams to ensure product success.
• FDA Compliance: Ensure that all products under development comply with FDA regulations and other healthcare-related standards. Lead efforts in the preparation and submission of necessary documentation for regulatory approvals.
• Technology Integration: Oversee the integration of software and hardware systems, ensuring seamless communication and functionality between both components of the product.
• Innovation & Problem-Solving: Leverage your expertise to drive the development of novel solutions for unmet healthcare needs. Propose and implement strategies to overcome technical challenges and deliver products on time and within budget.
• Stakeholder Communication: Regularly update the CTO and executive leadership team on the progress of development, potential roadblocks, and strategies for overcoming them.
• Mentorship: Provide leadership and mentorship to junior engineers and teams, fostering a culture of continuous learning and technical excellence.

REQUIREMENTS:

Required Qualifications:

• Advanced degree (Master’s or Ph.D.) in Engineering, Computer Science, Biomedical Engineering, or a related field
• Years of experience -??
• Proven experience as a Senior Engineer, R&D Manager, or equivalent role within a medical technology, life sciences, or healthcare company
• Extensive experience in both hardware and software product development, with a focus on medical devices or life science applications.
• Strong background in AI and digital technologies applied to healthcare, with a track record of successful product delivery.
• In-depth knowledge of FDA regulations and experience with regulatory submissions, including 510(k), PMA, and other relevant pathways.
• Strong leadership skills with the ability to manage cross-functional teams, mentor engineers, and collaborate effectively with senior leadership.
• Excellent communication and problem-solving skills, with the ability to drive innovation and solve complex technical challenges.
• Demonstrated ability to manage product development from concept through to commercialization, ensuring successful launch and scaling of products.

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 employ