Sr. R&D Manager

About the Role Paragonix Technologies (a Getinge organization) is seeking a Sr. R&D Manager to lead the design and development of transplant preservation devices, coordinating cross-functional teams to align R&D with business goals and advance organ preservation technology. What You'll Do

• Lead the design, prototyping, and evaluation of innovative transplant devices, integrating advanced technologies to enhance organ preservation methods.
• Assess potential intellectual property opportunities related to organ transplantation and preservation.
• Oversee projects from concept through feasibility, verification, validation, and design transfer to manufacturing, ensuring compliance with ISO 13485 and FDA regulations.
• Partner with marketing, regulatory affairs, quality assurance, and manufacturing teams to ensure regulatory compliance and commercial feasibility.
• Review design outputs (e.g., schematics, CAD models, PCB layouts) and manage design controls to minimize risks (ISO 14971).
• Recruit, mentor, and manage a team of high-performing engineers, fostering a culture of innovation and critical thinking.
• Manage competing priorities and organizational change by clarifying tradeoffs, communicating decisions, and maintaining strong team engagement.
• Oversee relationships with external vendors, consultants, and partners. What We're Looking For
• Demonstrated basic understanding of medical device regulatory standards and frameworks, including ISO 14971 for risk management throughout the product lifecycle, IEC 62366 and FDA human factors guidance for usability engineering.
• Experience with design controls and compliance with ISO 13485 and FDA regulations.
• Ability to lead, mentor, and manage a team of engineers; strong cross-functional collaboration.
• Experience partnering with marketing, regulatory affairs, quality assurance, and manufacturing to ensure regulatory compliance and commercial feasibility. Compensation & Benefits
• Salary: The minimum base salary for this position is $160.
• Work arrangement: Hybrid (1-2 days remote) with US-based candidate scope.