Senior Project Manager - R&D

1h1 hour ago

Weekday

San Clemente, US · Full-time · $130,000 – $165,000

About this role

We are seeking 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. This hybrid role is based in San Clemente, CA and offers a long-term opportunity for a self-driven individual.

In this role, you will oversee project execution from initial concept through to commercialization, managing schedules, budgets, resources, risks, and deliverables. You will support design control activities including product performance, assembly integrity, safety, labeling, packaging, and verification and validation tasks.

You will coordinate multidisciplinary teams such as Regulatory Affairs, Quality, Manufacturing, Operations, Marketing, and Supply Chain, driving alignment across cross-functional groups. The successful candidate should possess practical expertise in managing products throughout the entire medical device development process.

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. You will deliver executive-level project status updates and communications while ensuring compliance with FDA, ISO 13485, GMP, and MDR standards.

Requirements

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
Minimum of 4 years’ experience in Project Management within Medical Device or regulated healthcare industries
Skilled in MS Project, Excel, PowerPoint, SharePoint, and other related project management tools

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, and 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

Benefits

Hybrid work arrangement (San Clemente, CA)
Long-term role with competitive compensation
Opportunity to lead enterprise-level R&D projects in a highly regulated healthcare setting
Various shifts might be available with compensation varying based on the selected shift