Research and Development Project Manager

About the role

The role is for one of Weekday's clients. We are now hiring a Senior Project Manager - R&D for Medical Device New Product Development in San Clemente, CA (Hybrid).

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
• Cook up multidisciplinary teams including 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

Pay

Competitive Salary

Schedule

Long-Term Role. Various shifts might be available, with compensation varying based on the selected shift.