This role is open to US based candidatesParagonix Technologies develops organ preservation and transport technologies that help transplant teams protect donor organs during the journey from donor to recipient. Our portfolio supports cardiac, thoracic, abdominal, and multi-organ preservation and is focused on improving donor organ quality and transplant logistics. As we expand our thoracic portfolio, we are seeking a Senior Manager, R&D, to lead development of next-generation heart and lung preservation technologies with direct impact on patients, transplant centers, and organ procurement teams.
About the Opportunity:
Reporting to the Senior Director of R&D, the Senior Manager, R&D - Thoracic New Product Development will lead multidisciplinary engineering teams responsible for developing innovative medical devices from concept through commercialization. This is a highly visible leadership role with direct influence on product strategy, technology roadmaps, intellectual property, and the future of thoracic organ preservation.
- Lead development of technologies that directly impact transplant outcomes and help save lives.
- Shape the future of heart and lung preservation and transportation.
- Work alongside experts in engineering, transplantation, clinical care, and medical innovation.
- Influence product strategy, technology direction, and organizational growth.
- Join a fast-growing company where innovation, speed, execution, and accountability matter.
Primary responsibilities:
- Lead new product development programs for thoracic preservation and transport technologies.
- Drive innovation from concept generation through feasibility, design, verification, validation, and manufacturing transfer.
- Build and lead high-performing engineering teams while fostering innovation, accountability, and technical excellence.
- Define technical strategy, product architecture, development priorities, and technology roadmaps.
- Partner with Clinical, Regulatory, Quality, Marketing, Operations, and Manufacturing teams to deliver successful products.
- Identify intellectual property opportunities and contribute to Paragonix's innovation pipeline.
- Manage technical risk and ensure compliance with FDA design control expectations, ISO 13485, and ISO 14971.
Required Qualifications:
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering discipline.
- 10+ years of medical device product development experience.
- 3+ years leading engineering teams or direct reports.
- Proven success developing products from concept through commercialization.
- Strong understanding of design controls, risk management, and regulated product development.
- Experience with plastics, injection molding, medical device assembly, or related manufacturing processes.
- Experience with CAD tools; SolidWorks preferred.
- Strong communication, leadership, prioritization, and problem-solving skills.
- Experience developing Class II
Preferred Qualification:
- Master's degree in Engineering, Biomedical Engineering, or related technical field.
- Experience developing Class III medical devices.
- Experience with electromechanical systems, monitoring technologies, disposables, or capital equipment.
- Experience in transplant, thoracic, cardiac, respiratory, perfusion, critical care, or adjacent healthcare technologies.
- Knowledge of IEC 62366, FDA human factors guidance, ISO 10993, and IEC 60601.
- Experience contributing to patents, invention disclosures, or technology strategy.
General responsibilities:
- Onsite personnel
- Must be willing to travel 15%
US BASED SALARY - The minimum base salary for this position is $160,000 and the maximum salary is $175,000 plus 10% in annual bonus.
#LI-YA2 #LI-Onsite
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
