Project Manager

Job Description

Job Title : Manager, Project / Program Management – Medical Device Product Development

Location : Irvine, CA (Onsite)

Rate : $60–$70 / hr on W-2 (No C2C)

Type : Contract

Overview

We are seeking an experienced Project / Program Manager with a strong background in the medical device industry to lead cross-functional teams through the full lifecycle of patient-facing product development —from concept and design through clinical evaluation, operational readiness, and commercialization .

This role is critical in ensuring all new and improved medical device products and accessories used on patients meet the highest standards of safety, quality, and regulatory compliance , while achieving on-time delivery and alignment with business objectives.

Key Responsibilities

• Lead and execute complex medical device development programs , ensuring compliance with FDA, ISO 13485 , and internal Quality Systems .
• Oversee end-to-end product lifecycle for devices used in clinical and patient settings, including hardware, software, and disposables.
• Develop and manage project plans, schedules, budgets, risk registers , and resource allocation to meet program goals.
• Drive cross-functional collaboration between engineering, quality, regulatory, manufacturing, and clinical teams.
• Implement and maintain Change Control , Design Controls , and Risk Management processes throughout the development cycle.
• Lead program governance , including regular status updates, stakeholder reports , and executive presentations .
• Mentor and guide project management peers to ensure consistency and excellence in delivery.
• Champion a culture of quality, accountability, and continuous improvement across teams.
• Serve as the primary liaison with internal leadership, external partners, and regulatory bodies as needed.

Required Experience & Skills

Preferred Qualifications