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Weekday AI

Research and Development Project Manager

SalaryNo pay range posted
LocationSan Clemente, California, United States
Work modehybrid
Typefull-time
SenioritySenior
Experience4+ yrs
DepartmentWeekday's Client via platform
Company size10,000+ people
PostedJun 1, 2026 · 4mo ago
Verified live14h ago
California law requires most employers to post a pay range.
At a glanceSummarised by Seekless from the posting.
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
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
Skills
MS Project
Excel
PowerPoint
SharePoint
This role is for one of the Weekday’s clients
About the role
🚨 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
Responsibilities
🔹 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
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