Job Summary
The Project Manager leads cross-functional new product development projects for in vitro diagnostic (IVD) assays and diagnostic instrument systems in an FDA-regulated medical device environment. This role is accountable for project planning and execution from concept through launch, with emphasis on design control compliance, schedule, risk, resources, budget, and clear decision-making. The Project Manager partners with R&D, Regulatory Affairs, Quality, Clinical Affairs, Operations, Marketing, and external development partners to achieve business and product objectives. The position may be based locally in Cincinnati or performed remotely, with travel as required to support project teams and key milestones.
Key Duties
• Partner with R&D, Operations, Regulatory Affairs, Quality, Clinical Affairs, Finance, and Marketing and others to define project scope, goals and deliverables as well as successfully manage projects • Develops accurate, achievable project plans and timeline, consistently communicating the plans with team members and the leadership team
• Drives team ownership and commitment to project plans and recommends changes when necessary to meet project outputs • Tracks and communicates project performance, specifically to analyze successful completion of short- and long-term goals • Ensures on-time completion of tasks as required by the project and/or company procedures • Facilitates cross-functional project team meetings • Other duties as assigned
Qualifications
• Bachelor’s degree in science, engineering or business administration or related field required; advanced degree preferred. • At least 5 years of project management experience leading cross-functional product development projects. • Direct experience managing FDA-regulated medical device product development projects. • Working knowledge of medical device design control requirements and product development processes, including design planning, design reviews, risk • Preferred: Experience with in vitro diagnostic (IVD) products, including assay and/or diagnostic instrument development. • Preferred: Experience working within Quality Management Systems compliant with FDA 21 CFR Part 820 and applicable medical device regulations. • Preferred: Project management qualification (PMP) or equivalent.
• Demonstrated Project Management skills with proven record of practical project management experience preferably in the diagnostic or related biotechnical field • Demonstrate successful management of product(s) from concept to launch • Must have the ability to perform critical path identification • Excellent problem-solving skills. Must be a self-starter, detail oriented and able to prioritize and balance workloads and timelines and ability to work on multiple projects simultaneously • Must be able to work independently as well as collaboratively with peers and colleagues in a cross functional setting • Must be well organized and have the ability to meet strict deadlines and perform under pressure in a fast-paced work environment • Excellent interpersonal, organizational and written and oral communication skills
• Basic understanding of device development, engineering, and manufacturing activities is a plus
• 20% travel
