Project Manager

📋 Description

• Partner with Research & Development, Operations, Regulatory Affairs, Quality, Clinical Affairs
• Lead cross-functional product development projects from concept through launch, ensuring activities
• Develop accurate, achievable project plans, schedules, milestones, and timelines, and communicate
• Drive ownership and accountability across project teams while recommending adjustments to plans
• Track project performance against short- and long-term objectives, proactively identifying risks
• Ensure project tasks and deliverables are completed on schedule and in accordance with established

🎯 Requirements

• A Bachelor's degree in Science, Engineering, Business Administration, or a related field is
• At least 5 years of project management experience leading cross-functional product development
• Direct experience managing product development projects within an FDA-regulated medical device
• Working knowledge of medical device design control requirements and product development processes
• Demonstrated experience successfully managing products from concept through launch.
• Experience in the diagnostic, biotechnology, medical device, or related life sciences industry is

🎁 Benefits

• Opportunity to lead innovative diagnostic product development projects from concept through launch.
• Exposure to multidisciplinary teams spanning Research & Development, Regulatory Affairs
• Opportunity to work within an FDA-regulated medical device and in vitro diagnostic development
• Position may be performed remotely within the United States or locally in Cincinnati.
• Approximately 20% travel to support project teams and important project milestones.
• Professional exposure to medical device design controls, regulatory processes, quality systems, and