Project Manager
New
J
JobgetherMedical Devices
Position may be performed remotely within the United States or locally in Cincinnati.Full-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- At least 5 years of project management experience
- Required Skills
- Project ManagementCross-functional Team LeadershipProduct DevelopmentRisk Management
Requirements
- Bachelor’s degree in Science, Engineering, Business Administration, or a related field (Advanced degree preferred).
- At least 5 years of experience leading cross-functional product development projects.
- Direct experience managing product development within an FDA-regulated medical device environment.
- Working knowledge of medical device design control requirements (design planning, design reviews, risk management).
- Demonstrated success managing products from concept through launch.
- Familiarity with Quality Management Systems (QMS) compliant with FDA 21 CFR Part 820.
- Experience in diagnostic, biotechnology, or life sciences industry preferred.
- PMP certification or equivalent qualification preferred.
- Ability to identify and manage critical paths, risks, and schedules in complex environments.
- Willingness to travel approximately 20% of the time.
Responsibilities
- Partner with R&D, Operations, Regulatory, Quality, Clinical, Finance, and Marketing stakeholders to define project scope and deliverables.
- Lead cross-functional product development projects from concept through launch.
- Develop and communicate accurate project plans, schedules, and milestones.
- Drive team accountability and recommend adjustments to plans or resources as needed.
- Track performance and proactively identify risks, dependencies, and improvement opportunities.
- Ensure compliance with design controls and regulatory requirements throughout the lifecycle.
- Facilitate project meetings and maintain alignment across cross-functional teams.
- Identify and manage critical paths to ensure key milestones are met.
- Support budget oversight, resource planning, and risk management.
- Maintain project documentation and provide regular status reporting.
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