Research and Development Project Manager

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.

Must-have skills

R&D medical device Medical Devices Medical Device R&D Biomedical Device Design Biomedical Devices