Overview
Research and Development Project Manager Jobs in San Clemente, CA at Weekday AI (YC W21)
Title: Research and Development Project Manager
Company: Weekday AI (YC W21)
Location: San Clemente, CA
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