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.

🔹 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