R&D Manager
- 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
- 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.
- Onsite personnel
- Must be willing to travel 15%
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