This role is for one of the Weekday's clients
Now Hiring: Senior Project Manager – R&D | Medical Device New Product Development
San Clemente, CA (Hybrid)
Competitive Salary | Long-Term Role
Various shifts might be available, with compensation varying based on the selected shift.
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.
Requirements
Qualifications We Seek:
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
Primary 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
Required Qualifications:
• 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
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.
R&D medical device Medical Devices Medical Device R&D Biomedical Device Design Biomedical Devices