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