Sr Product Development Engineer

Getinge•North Waltham, MA

1d•Onsite

About The Position

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community. The company offers a leading commercial system for heart preservation and transportation, while actively broadening its solutions for preserving all solid organs. As a Senior Product Development Engineer, you will be responsible for designing and developing innovative solutions for next-generation organ preservation systems. In this role, you will collaborate with specialized teams, applying technical expertise to enhance the existing product portfolio and drive pipeline advancement through innovation, design, development, verification, validation, and successful launch of electro-mechanical systems.

Requirements

Experience in a regulated FDA/GMP environment, with strong understanding of quality systems (ISO 13485) and risk management (ISO 14971).
Demonstrated experience in the design, development, and successful commercialization medical devices from concept to launch in compliance with 60601-1.
Proven ability to create robust, manufacturable, and practical design solutions for complex challenges.
Track record of leading products through the concept phase to manufacturing transfer.
Excellent communication, collaboration, problem-solving, root cause analysis, and critical thinking skills.
Minimum of 5 years’ experience in medical device design and development.
Highly self-motivated, with a passion for addressing complex problems.
Proficiency in SolidWorks is required.
Competence in designing for injection molding.
Bachelor’s degree in a relevant engineering discipline is required

Nice To Haves

an advanced degree is preferred.

Responsibilities

Design and implement mechanical and electrical solutions to advance new product development initiatives.
Collaborate with multidisciplinary teams to interpret customer requirements and translate them into clear technical specifications.
Evaluate design solutions utilizing both experimental methods and analytical techniques.
Research and assess emerging technologies and components to identify opportunities for product innovation and enhancement.
Develop and maintain thorough design specifications, 3D CAD models, engineering drawings, and related documentation.
Prepare and deliver engineering documentation, ensuring effective communication of results to technical teams, manufacturing partners, and Paragonix leadership.
Establish rigorous evaluation protocols to confirm that design solutions meet all verification and validation requirements.
Ensure that all design and development activities adhere to the company’s Quality Management System (QMS) and comply with applicable medical device standards.