Senior Director R&D US

Job Description:

TransMedics was founded to address the unmet need for more and better organs for transplantation and has developed the Organ Care System (OCS) technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung, and liver failure. TransMedics' National OCS Procurement (NOP) program was developed to maximize the utilization of donor organs in the US.

TransMedics is hiring for a Senior Director, R&D based in Andover, MA

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• The Senior Director for R&D will lead all next-gen OCS technology development activities in Andover. This will include hardware, systems engineering, design controls & perfusion disposables in partnership with our Mirandola team.
• This role will provide strategic leadership to both internal TMDX product development teams based in Andover as well as outside third-party product development partners.
• This role will partner with the R&D leadership and CTO to reshape the TMDX Andover based product development teams to maximize productivity, efficiency of execution of our mission critical product development deliverables.
• This role will additionally partner with the commercial, clinical, manufacturing, and strategic leadership for TMDX to support the product development roadmap for the Company influencing executive-level decisions and cross-functional integration.
• It is imperative to have physical presence in Andover to ensure proper alignment with TMDX goals, understanding of the business and assess the current internal product development team.
• This role will work collaboratively with TMDX QA and Supply chain teams to ensure that all product development are meeting our internal QMS requirements and that development partners are of the highest quality.
• You and the team will collaborate with TMDX's New Product Introduction team in Andover to ensure all designs are ready for automated or semi-automated assembly and ready for manufacturing.
• Will be a key member of the R&D leadership team for TMDX.
• Stakeholder alignment - Clarify the candidate

MANAGEMENT RESPONSIBILITIES

• Lead, mentor, and support the Andover R&D team, promoting a culture of innovation, collaboration, and high performance.
• Conduct performance evaluations, provide feedback, and identify opportunities for professional development.
• Encourage continuous learning and stay updated with the latest scientific and technological advancements to ensure the team operates at the cutting edge of the industry.
• Communicate the progress, challenges, and outcomes of R&D projects to senior management, providing regular updates and recommendations for future actions.
• Manage relationships with external partners, including universities, research institutions, and suppliers, to foster collaboration and access innovative technologies or knowledge.
• Emphasis on high-level innovation, portfolio prioritization, risk management, and budgetary accountability.
• Ensure that all R&D activities comply with relevant medical device industry regulations (FDA, CE etc.) quality standards, and safety protocols.
• Oversee the proper documentation of research activities, including patents, product certifications, and technical reports, to protect intellectual property and ensure regulatory compliance

MINIMUM QUALIFICATIONS

• Advanced degree (Master's / PhD) in a relevant technical field (e.g. Engineering, computer science).
• 10+ years of experience in R&D, with at least 6+ years in a managerial or leadership role in the medical device industry
• Strong project management skills, with experience leading complex research projects from concept to completion.
• Record of accomplishment of successful commercial product launches in the MedTech sector
• Excellent communication and leadership abilities.
• Knowledge of regulatory requirements and industry standards in the medical device industry.

PREFERRED QUALIFICATIONS

• Background in software, connectivity, automation, or data integration is highly desirable.
• Certified Project Manager (CPM) focused on the skills necessary to manage complex R&D projects effectively.
• Certified Research Administrator (CRA)n to oversee the administration and management of research programs, ensuring adherence to policies and regulations.
• Lean Six Sigma Certification providing knowledge of process improvement techniques, which are valuable to streamlining workflows and improve productivity

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.