Project Manager - Technical Transfer - Medical Devices #9235 Taunton, MA
- Lead end-to-end technology transfer projects, from planning through validation and production release.
- Manage clients’ customer communications
- Develop and manage detailed project plans, timelines, budgets, and risk mitigation strategies.
- Coordinate cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Supply Chain.
- Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards.
- Oversee process validation, equipment qualification, and documentation transfer.
- Drive continuous improvement in transfer processes to ensure timely completion of deliverables and ensure product quality.
- Communicate project status, risks, and milestones to senior leadership and stakeholders.
- Responsible for coordination, implementation, execution, control, and completion of assigned project(s)
- Provide project management support to assigned project(s)
- Responsible for the overall project management specifically focused on ensuring overall client satisfaction and quality of delivery, and performance of the engagement
- Develop resource plans and facilitate resource loading activities
- Develop workflows for project optimization
- Utilize appropriate project management tools and techniques to drive project execution
- Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
- 5+ years of experience in medical device manufacturing, product development, or technology transfer.
- Proven track record managing complex, multi-site projects in a regulated environment.
- Strong knowledge of design control, process validation, and manufacturing scale-up.
- Results-oriented, positive attitude focused on delivering timely, accurate and best in class execution
- Ability to draw conclusions and make business recommendations based on cross-functional team input
- Exceptional leadership, communication, and problem-solving skills.
- PMP certification or equivalent project management training preferred.
- Proficiency in MS Office applications including MS Project
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