Job Description
Job Description
Description Introduction
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, lung, liver and pancreas. As we grow, we are looking to add an R&D Manager reporting to the Sr. R&D Director. This newly created position will be responsible for the development of novel solutions in transplant care and collaborate 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.
Primary responsibilities will include:
- Manage new product development planning and execution of novel products in partnership with marketing, program management, operations, regulatory and quality team-members to support the Paragonix pipeline
- Provide technical oversight to product development teams needed to meet project deliverables
- Oversee planning and execution of product development documentation to satisfy Design History Files
- Support FDA regulatory submissions
- Manage R&D direct reports, providing direction, mentorship and opportunities for growth
- Engage hand-on with engineering team to design, develop and test novel concepts
- Support R&D personnel hiring and development
- Contribute to the creation of intellectual property
- Contribute to improving processes & procedures to drive innovation
Qualifications:
- Previous history in demonstrating strong problem solving and decision-making skills
- 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
- Bachelor's degree in an applicable engineering discipline required
- General knowledge of compliance requirements for FDA regulatory medical devices
- Demonstrated ability to lead engineering teams and direct reports through product development process
- 8+ years of medical device development experience
- 3+ years managing director reports
- Previous CAD experience required. Solid Works preferred.
General responsibilities:
- Onsite personnel
- Must be willing to travel 15%
Description Conclusion