Job Description

A major medical device company in Irvine, CA is in immediate need of a Program Manager consultant for at least 6 months (potential extension for additional 6 months). This is a fully onsite position.

This consultant will support the Senior Director of Program Management and cross-functional teams to support material changes, product redesign efforts, and other areas as needed.

Responsibilities :

• Lead and manage cross-functional projects related to product development, quality improvement, or process optimization.
• Develop project plans, timelines, resource allocations, and risk management strategies.
• Track and report project/program status, deliverables, budgets, and milestones to stakeholders and senior leadership.
• Facilitate effective communication between departments.
• Ensure project documentation meets internal standards and complies with relevant regulatory requirements (e.g., FDA 21 CFR Part 820, EU MDR).

Top Requirements :

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5+ years of project and program management experience, with at least 2 years in the medical device industry.
• Strong knowledge of medical device regulations, including FDA and ISO 13485.
• Proven ability to manage complex projects with multiple stakeholders and deliver results on time and within budget.
• Excellent organizational, communication, and interpersonal skills.
• Proficiency with project management and collaboration tools.

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