# Research and Development Project Manager

**Company:** [Weekday AI](http://jobs.workable.com/companies/pxG9rDgnvZm2c86JUchT1j.md)
**Location:** San Clemente, United States
**Workplace:** hybrid
**Employment type:** Full-time
**Department:** Weekday's Client via platform

[Apply for this job](http://jobs.workable.com/view/5cee2dbf-ba0d-430e-a5ec-2f64bdc6c788)

## Description

**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