Sr. Sustaining R&D Engineer

Getinge•Boston, MA

1d•Onsite

About The Position

Getinge is a medical technology company that provides products and solutions for hospitals and life science institutions, aiming to improve clinical results and optimize workflows. They employ over 12,000 people worldwide. Paragonix Technologies, a rapidly growing medical device manufacturer, designs, manufactures, and sells organ transplant transport devices. The company offers a leading commercial system for heart preservation and transportation and is actively broadening its solutions for preserving all solid organs. As a Senior Research & Development Sustaining Engineer, you will be responsible for designing and developing innovative solutions for currently marketed 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 sustaining 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).
Proven ability to create robust, manufacturable, and practical design solutions for complex challenges.
Track record of leading products through iterative life cycle changes.
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 address sustaining engineering initiatives.
Collaborate with multidisciplinary teams to identify and address design improvements in existing products.
Evaluate design solutions utilizing both experimental methods and analytical techniques.
Foster strong working relationships with contract manufacturers and vendors, developing and maintaining project timelines to ensure project commitments are met.
Develop and maintain robust design specifications, 3D CAD models, engineering drawings and documentation.
Prepare and deliver engineering documentation, ensuring effective communication of results to technical teams, manufacturing partners, and Paragonix leadership.
Establish rigorous 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.