Engineer II, Product Development

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

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 screeningto 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.

Primary Responsibilities Include:

• 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.

Qualifications:

• 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; an advanced degree is preferred.

General Responsibilities:

• Onsite role
• Willingness to travel 10%-15%.

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.