Research and Development Project Manager
About The Position
We are currently looking for a seasoned Senior Project Manager with extensive experience in Medical Device New Product Development (NPD) to lead enterprise-level R&D projects within a highly regulated healthcare setting. The successful candidate should possess practical expertise in managing products throughout the entire medical device development process — including design inputs, verification and validation, regulatory submissions, and product launch. This role represents a fantastic opportunity for a self-driven individual who excels in early-stage product development and can lead execution across multiple teams independently.
Requirements
- Bachelor’s degree mandatory
- Minimum of 4 years’ experience in Project Management within Medical Device or regulated healthcare industries
- Experience in Design Controls and Medical Device Development Lifecycle
- Strong comprehension of NPD processes and regulatory frameworks
- Skilled in MS Project, Excel, PowerPoint, SharePoint, and other related project management tools
- R&D medical device
- Medical Devices
- Medical Device R&D
- Biomedical Device Design
- Biomedical Devices
Nice To Haves
- Extensive experience in Medical Device New Product Development (NPD)
- In-depth knowledge of Design Controls
- Proven background in supporting FDA 510(k), MDR, and other regulatory submissions
- Capacity to perform effectively in fast-paced and ambiguous R&D settings
- Demonstrated track record of driving alignment across cross-functional teams including R&D, Regulatory, Quality, Operations, and Supply Chain
- Experience with supporting product launch and ongoing sustaining engineering efforts
Responsibilities
- Lead complex R&D and New Product Development initiatives within FDA-regulated contexts
- Oversee project execution from initial concept through to commercialization
- Manage schedules, budgets, resources, risks, and deliverables associated with projects
- Coordinate multidisciplinary teams such as Regulatory Affairs, Quality, Manufacturing, Operations, Marketing, and Supply Chain
- Support design control activities, including product performance, assembly integrity, safety, labeling, packaging, as well as verification and validation tasks
- Collaborate with stakeholders to establish project scope, validation strategies, and requirements in dynamic development environments
- Ensure compliance of all projects with FDA, ISO 13485, GMP, and MDR standards
- Deliver executive-level project status updates and communications
Benefits
- Competitive Salary
- Long-Term Role
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What This Job Offers
Job Type
Full-time
Career Level
Senior
