Director, R&D and Product Development

Director, R&D and New Product Development

Location: Brecksville, OH, transitioning to Wickliffe, OH in 2028.

Job Type: Hybrid. 4 days on site.

• Define and execute the global medical device NPD strategy aligned with business growth priorities, customer roadmaps, and portfolio strategy.
• Identify and pursue adjacent medical device applications where our technologies and platforms can create differentiated value and drive organic growth.
• Lead capability road mapping to define and build the new technical, testing, and development capabilities the group must invest in to sustain growth and capture high value programs.
• Establish scalable development governance, stage-gate rigor, and portfolio prioritization to ensure consistent execution excellence.
• Oversee complex, multi-site development programs from concept through commercialization, ensuring delivery to cost, schedule, performance, and quality expectations.
• Partner with Quality and Regulatory to ensure compliance with FDA, CE/MDR, ISO 13485, and applicable global regulatory requirements.
• Serve as senior technical interface with strategic OEM customers, supporting complex development engagements and long-term partnerships.
• Collaborate with Commercial, Marketing, and Business Development to shape development proposals, technology roadmaps, and differentiated customer solutions.
• Champion design-for-manufacturability, design-for-quality, and design-for-cost principles across global manufacturing platforms.
• Ensure effective transfer of products from NPD to Manufacturing, preserving design intent, robustness, and scalability during launch and ramp-up.
• Lead and develop a global organization of NPD engineers, scientists, and program leaders across multiple regions and sites.
• Build technical bench strength through hiring, development, coaching, and succession planning.

• Bachelor’s degree in Mechanical, Biomedical, Chemical Engineering, or related technical discipline; advanced degree preferred.
• 10 or more years of progressive experience in medical device product development in a regulated environment, including experience in thermoplastic precision extrusion and silicone processing.
• Demonstrated experience leading global or multi-site technical teams.
• Strong working knowledge of FDA design controls, ISO 13485, FDA 21 CFR Part 820, and CE/MDR requirements.
• Proven track record delivering complex development programs from concept through commercialization and manufacturing transfer.

• Advanced technical degree (MS or PhD).
• Experience with catheter-based or minimally invasive medical device technologies.
• Strong understanding of polymer-based medical devices and associated manufacturing processes.
• Formal training or certification in program or portfolio management.
• Experience operating effectively within matrixed global organizations.

• Competitive salary with performance-based bonus plans
• 401(k) match + Age-Weighted Defined Contribution
• Health Savings Account (HSA)
• Paid holidays, vacation, and parental leave