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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 their 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.
Job Responsibility:
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
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