R&D Manager
About The Position
Vein360 is looking for an R&D Manager to lead a talented team of development engineers and project managers at the forefront of medical device restoration. Transforming previously used healthcare products into like-new, market-ready solutions. This is a rare opportunity to blend hands-on technical leadership with strategic influence, shaping both the products we deliver and the people who build them. This position is based full-time at our Cincinnati, OH facility. It is not eligible for remote or hybrid work. You'll own the full lifecycle of product development, from concept through regulatory submission, while mentoring a high-performing engineering team. If you thrive at the intersection of technical rigor, regulatory expertise, and people leadership, this is your next challenge.
Requirements
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field
- 7+ years of experience in medical devices or a closely related industry
- Strong command of MS Office
- Exceptional organizational skills and a sharp eye for documentation and detail
- Proven ability to write and implement advanced technical procedures
- A creative problem-solver who thrives amidst change
- A confident communicator and self-starter who can lead, motivate, and, when needed, manage performance and disciplinary matters with fairness and professionalism
Nice To Haves
- Master's degree
- Familiarity with Visio and Project
- Instructor-level proficiency in CAD software (SolidWorks, Creo, or similar) preferred
Responsibilities
- Lead and develop a team of engineers and project managers, driving successful, on-time product delivery
- Own the 510(k) submission process from drafting through approval
- Maintain rigorous Design History File documentation and ensure full compliance with 21 CFR Part 820 and other applicable regulations
- Review and approve critical technical documentation, including drawings, test protocols, and reports
- Manage departmental budgets and resource allocation
- Stay ahead of evolving industry standards and regulatory requirements
- Drive alignment across cross-functional teams — Operations, Quality, R&D, and Finance
- Present project updates and departmental progress directly to senior leadership
- Build strategic vendor and contractor relationships to support product and process development
- Recruit, interview, and grow your team as the department scales
- Champion a safe, inclusive, and collaborative team culture
Benefits
- Mission-driven team
- Sustainable, high-impact medical technology
- Autonomy to lead
- Resources to innovate
- Visibility to make a real difference at the leadership table
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What This Job Offers
Job Type
Full-time
Career Level
Manager
