R&D Program Manager, Medical Devices

Millenniumsoft; Irvine (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Millenniumsoft in Irvine, CA is seeking an experienced R&D Project Manager for a 12-month contract to lead multi-disciplinary teams through product development, clinical evaluations, operational readiness and commercialization.

The role requires initiating, planning, budgeting, executing, controlling and delivering on-time product launches while upholding quality standards. Strong knowledge of medical device regulations and cross-functional leadership are essential.

Qualifications

• 5+ years managing New Product Development projects/programs.
• Experience in the medical device industry with software, firmware, hardware & disposables.
• Knowledge of Medical Device Regulations and Product Development Process.
• Strong management skills in complex organizations.
• Proficient with MS Office and project management systems.
• Big-picture thinking and business-aligned action.
• Strong analytical skills for data-driven decisions.
• Ability to work in a matrix organization and negotiate priorities.

Responsibilities

• Manage large-scale projects/programs with adherence to Quality Systems and Change Control.
• Create and approve business cases and coordinate resource sharing and prioritization.
• Develop detailed program plans and manage changes.
• Implement program strategies for quality assurance, risk management, communications and staffing.
• Lead core team meetings and optimize processes and workflows.
• Serve as PM SME and mentor peers.
• Demonstrate emotional intelligence and build trust with stakeholders.
• Foster urgency and accountability to meet goals.
• Analyze complex problems and drive effective resolutions.
• Influence downward, horizontally, and upward to balance priorities.

Skills

Project management

Leadership

Risk management

Communication

Emotional intelligence

Decision-making

Cross-functional collaboration

Stakeholder management

Education

Bachelor's Degree in STEM or related field

Master's Degree or equivalent - Preferred

PMP/Agile/Scrum Certification - Plus

Tools

Jira

Microsoft DevOps

Job description

Millenniumsoft in Irvine, CA is seeking an experienced R&D Project Manager for a 12-month contract to lead multi-disciplinary teams through product development, clinical evaluations, operational readiness and commercialization.

The role requires initiating, planning, budgeting, executing, controlling and delivering on-time product launches while upholding quality standards. Strong knowledge of medical device regulations and cross-functional leadership are essential.