Scrum-Certified Project Manager Medical Device R&D Focus

$108,160 - $119,600/Yr

Hydrogen Group - Irvine, CA

Full-time - Mid Level

Irvine, CA

Administrative and Support Services

About the position

The Scrum-Certified Project Manager will oversee medical device development projects, focusing on cardiovascular products. This role requires a strong background in Agile methodology and experience in managing cross-functional teams in a regulated environment. The position is contract-based for 16-18 months and involves leading projects from planning through development while ensuring compliance with quality systems and regulatory standards.

Responsibilities

• Develop a high-level integrated milestone plan for projects, managing scope, quality, schedule, cost, and contracts.
• Serve as Scrum Master, collaborating with R&D and product teams to manage and coordinate sprints using Agile methodology.
• Facilitate sprint planning, daily stand-up meetings, sprint reviews, and track sprint metrics.
• Apply a modified Scrum framework tailored for physical device development, ensuring compliance with quality systems and regulatory standards.
• Establish and maintain strong relationships with internal and external stakeholders, managing expectations and communication effectively throughout the project lifecycle.
• Ensure projects meet Design Control requirements in line with the Edwards Quality System.
• Manage the Design History Files within the document system and coordinate preparations for technical and design control phase gate reviews.

Requirements

• Bachelor's degree in Engineering (preferred) or a related field.
• Minimum of 5 years of project management experience in the medical device or pharmaceutical industry.
• Certified Scrum Master with strong Agile methodology expertise.
• Direct experience in physical device development is essential.

Nice-to-haves

• Experience with Windchill or similar PLM software to manage and document design control.
• Demonstrated experience in regulated environments, specifically medical device development.

Benefits

• Competitive pay range of $52-57.50/hr depending on experience.
• Opportunity to work in a dynamic and innovative industry.