Research and Development Project Manager

A growing medical device innovator is seeking a Research & Development Project Manager to lead product development from early concept through production transfer. This role requires someone who can balance technical execution with cross-functional coordination while supporting on-site operations at the Cincinnati facility. You’ll oversee project plans, maintain quality and regulatory compliance, manage timelines and budgets, and ensure clear communication across all stakeholder groups throughout the development lifecycle.

Key Responsibilities

• Lead medical device programs from inception to production, driving alignment across engineering, manufacturing, quality, regulatory, and operations.
• Develop and manage project plans—including schedules, resource allocation, budgets, and deliverables.
• Facilitate daily stand-ups and weekly team meetings to maintain progress and remove obstacles.
• Translate product needs into clear requirements and communicate effectively with stakeholders at all levels.
• Identify and track project risks, ensuring mitigation strategies are implemented and visible through dashboards.
• Prepare for and lead design reviews and stage-gate milestones; manage DHF updates, ECOs, and required project documentation.

Background Requirements

• Bachelor’s degree in Engineering or related field.
• 5+ years of hands-on experience in medical device R&D or Quality with direct product development involvement.
• Strong understanding of design controls, ISO 13485, and FDA QSR requirements.
• Proven ability to collaborate effectively across cross-functional teams and manage diverse stakeholders.
• Skilled in managing budgets, timelines, and shifting project priorities.
• Familiarity with applicable standards (e.g., ISO 14971, ISO 62304, IEC 60601-1) and directives including MDR, RoHS, REACH, WEEE.