Job Title: Program Manager IV

We are seeking a highly experienced Program Manager to lead Quality Assurance (QA) activities for a strategic M&A initiative in the medical device industry. This role will also direct a Project Manager overseeing Regulatory Affairs (RA) and Clinical Affairs (CA), and work independently but in coordination with the R&D Program Manager. The position is 100% onsite in Irvine, CA and requires a strong leader with deep industry expertise and exceptional cross-functional collaboration skills.

• Assemble and lead project teams, assign responsibilities, and identify resources to ensure timely project completion.
• Capture detailed customer requirements, constraints, and assumptions to define project deliverables.
• Develop strategy and planning documentation.
• Estimate, monitor, and manage project budgets throughout the lifecycle.
• Align stakeholders and team members by setting clear expectations and maintaining a shared understanding of project goals.
• Identify, assess, monitor, and close project risks proactively.
• Manage scope, schedule, and cost changes using verification techniques to maintain an accurate and approved project plan.
• Improve team performance through leadership, mentoring, and motivation to foster cooperation.
• Measure and report project performance using appropriate tools and techniques.
• Ensure stakeholder alignment and manage resource prioritization.
• Escalate employee performance and workflow issues as needed.
• Review and spot-check deliverables to ensure quality and compliance.

• Proven ability to analyze and resolve complex process and system issues using independent judgment.
• Strong interpersonal, communication, and negotiation skills.
• Ability to build trust and influence mid-level management and present effectively to executives.
• Skilled in generating and explaining detailed proposals, schedules, budgets, and documentation.
• Proficient in project management tools and software.
• Medical device industry experience is required, with a deep understanding of FDA regulations, ISO standards, and global quality systems.

• 10+ years of Project/Program Management experience in the medical device industry.
• Demonstrated success managing QA activities in M&A environments.
• Experience coordinating with RA and CA teams.
• PMP or equivalent certification preferred.
• Bachelor's Degree in Engineering.
• 8+ years of Project Management/Program Management experience.
• Experience with new product introduction, stakeholder alignment, and resource prioritization.

This position is based onsite in Irvine, CA. The work environment is dynamic and requires the use of various project management tools and Microsoft Project. The company offers 2 weeks of paid time off and client-paid holidays.

This is a Contract position based out of Irvine, California.