Principal Mechanical Engineer - Development Engineering

Job Description:

TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport. Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide. The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.

TransMedics is developing the Next Generation Organ Care System and is looking for an exceptional mechanical engineer with a proven track record of delivering innovative solutions to the disposable medical device market. This role is heavily focused on developing the next generation disposable for the Organ Care System. A strong technical background and expertise in injection molding and SolidWorks are required. The ideal candidate will be extremely creative, highly motivated and has brought complex medical disposables from concept to commercialization.

ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:

• Lead development of capital equipment for the OCS Heart, OCS Lung and OCS Liver product lines.
• Provide direction to multiple external industrial design teams and OEM manufacturers.
• Responsible for designing, building, and testing new concepts and iterating through the design process.
• Demonstrate subsystem reliability including development of test fixtures and protocols.
• Create drawings and release documentation in accordance with applicable standards and SOPs.
• Prepare documentation to support quality system for design functions (project plans, design input, risk assessment, test protocols and reports, drawing specifications, etc.)
• Create development strategies and provide direction to junior engineers, technicians, and interns.
• Collaborate and communicate with cross-functional teams and leadership.

BACKGROUND AND QUALIFICATIONS:

• 12+ years of product development experience as mechanical engineer with 8 years in a lead role for complex Class II or III medical capital equipment. Experience should include the full design cycle from concept to FDA approval.
• BS in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or equivalent is required.
• Expert in Solidworks 3D modeling and DFM design of plastic and metal components.
• Solid foundation of mechanical engineering fundamentals and ability to perform detailed engineering analysis including tolerance analysis & FEA.
• System architecture design experience with pneumatic and liquid control systems.
• Must be a creative problem solver that can think outside of the box to develop novel solutions to complex problems.
• Strong hands-on skills and ability to use power tools and light machine shop equipment.
• Previous experience with IEC 60601-1 mechanical design requirements and testing.
• Understanding of medical device development processes including experience with FDA CFR 820 and ISO 13485 regulations.
• Ability to work independently with high competency and little guidance.
• Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency.
• Strong written and verbal communication skills are required.

PREFERRED QUALIFICATIONS:

• Prior project management experience and Six Sigma Green Belt desired.

Every Organ Wasted is a Life Not Saved.

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.