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. Our company provides the leading commercial system for heart preservation and transportation as well as transplant systems for kidney, lungs, liver and pancreas. As we grow, we are looking to add a Sr. R&D Manager reporting to the Sr. R&D Director. This position will be responsible for collaborating with cross functional departments to align R&D effort with business goals. This role is crucial to continue fostering innovation and ensuring continued success in advancing transplant care. Job Responsibilities and Essential Duties • 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. Required Knowledge & Skills • 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 and use-related risk analysis, ISO 10993 for biocompatibility and biological evaluation of medical devices and materials, and IEC 60601 standards for electrical safety and essential performance of medical electrical equipment. • Bachelor's degree in engineering (Mechanical, Biomedical or related field). Master's degree preferred. • Minimum of 8 years of experience in engineering roles, with at least 3 years in a leadership or managerial position within the medical device industry. • Demonstrate understanding of design principles and requirements for injection molding and other plastic manufacturing methods. • Demonstrated ability to lead engineering teams and direct reports through various stages of product development process • Self-motivated with ability to think strategically and solve complex problems • Interpersonal skills to communicate, advise, negotiate or influence others, as well as build productive working relationships in various settings. • Previous CAD experience required. Solid Works preferred. 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.