R&D Program Lead — Medical Devices

MillenniumSoft Inc; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

MillenniumSoft Inc in Irvine, CA seeks an experienced R&D Project Manager to lead cross-functional teams through product development and commercialization of medical devices. You will manage scope, schedule, budgets, and quality systems, apply Agile practices (Jira, Microsoft DevOps), and drive risk management, communication, and timely delivery.

A Bachelor's in STEM is required; a Master's or PMP/Agile/Scrum certification is preferred.

Qualifications

• Bachelor's degree in STEM required; Master's preferred or equivalent experience.
• PMP/Agile/Scrum certification is a plus.
• Minimum 5 years of direct experience managing New Product Development projects in the medical device industry.
• Experience leading projects with software, firmware, hardware components and disposables.
• Familiarity with Medical Device Regulations and product development processes.

Responsibilities

• Lead one or more large-scale projects/programs ensuring adherence to Quality Systems and Change Control processes.
• Facilitate business case creation within the program and coordinate resource prioritization.
• Develop detailed program plans and manage program changes.
• Implement strategies related to quality assurance, risk management, communications, staffing, and other core areas; communicate status to stakeholders.
• Lead core team meetings and optimize meeting processes, decision-making, and workflows.
• Serve as a PM/Program Mgmt SME; mentor peers and drive cross-functional collaboration.
• Demonstrate high emotional intelligence; build trust and maintain momentum during crises or changes.
• Influence across downward, horizontal, and upward relationships to meet goals.

Skills

Project management

Leadership

Risk management

Strategic planning

Communication

Stakeholder management

Emotional intelligence

Education

Bachelor's degree in STEM

Master's degree or equivalent

PMP/Agile/Scrum Certification

Tools

Jira

Microsoft DevOps

MS Office Suite

Job description

MillenniumSoft Inc in Irvine, CA seeks an experienced R&D Project Manager to lead cross-functional teams through product development and commercialization of medical devices. You will manage scope, schedule, budgets, and quality systems, apply Agile practices (Jira, Microsoft DevOps), and drive risk management, communication, and timely delivery.

A Bachelor's in STEM is required; a Master's or PMP/Agile/Scrum certification is preferred.