R&D Project Manager - Onsite

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

• The Project Manager will be responsible for successfully leading project and program teams through various stages of product development, clinical evaluations, operational readiness, and commercialization for new and improved products and related accessories and disposables.
• The role involves initiating, planning, budgeting, executing, documenting, controlling, and managing all aspects of projects and programs to ensure on-time commercialization of new products and technologies that uphold Client's best-in-class quality standards and business objectives.

Job Title: R&D Project Manager

Duration: 12 months contract.

Location: Irvine, CA

Job Description

• The Project Manager will be responsible for successfully leading project and program teams through various stages of product development, clinical evaluations, operational readiness, and commercialization for new and improved products and related accessories and disposables.
• The role involves initiating, planning, budgeting, executing, documenting, controlling, and managing all aspects of projects and programs to ensure on-time commercialization of new products and technologies that uphold Client's best-in-class quality standards and business objectives.

Key Responsibilities

• Manage one or more large-scale projects/programs, ensuring strict adherence to Client's Quality Systems and Change Control Process.
• Facilitate the creation and approval of business cases within the program and coordinate the sharing and prioritization of resources among projects.
• Develop a detailed plan for the program and manage program changes accordingly.
• Implement program strategies related to quality assurance, risk management, communications, staffing, and other core areas. and communicate program status and data to maintain accurate and current program information for stakeholders.
• Facilitate core team meetings and other required meetings to support program execution; regularly assess and enhance meeting processes, decision-making, and workflows.
• Serve as a project and program management subject matter expert, including guiding and mentoring peers.
• Demonstrate high emotional intelligence; build trust, rapport, and respect with project team members and stakeholders; engage in honest and transparent conversations.
• Create a culture where teams can act with a high sense of urgency and accountability to meet/exceed individual and project goals.
• Understand complex problems and drive the team to effective resolution.
• Display perseverance and maintain appropriate forward momentum by keeping the core team engaged, even when faced with crises and/or changes.
• Demonstrate strong ability to influence downward, horizontally, and upward.

Experience

• A minimum of 5 years of direct experience managing New Product Development projects and/or programs of increasing complexity.
• Demonstrates a record of successfully managing and leading projects in the medical device industry that incorporate a mix of Software, Firmware, and Thermoplastic Hardware and Disposable components.
• Proficient understanding of Medical Device Regulations and Product Development Process.
• Demonstrated record of leading within complex organizations require strong management skills.
• Proven expertise in the usage of MS Office Suite and related project management systems.
• Ability to see the "big picture" and determine the course of action from an overall "best for the business" perspective.
• Strong analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to work cooperatively at all levels in a matrix environment to build and maintain the positive relationships required to accomplish organizational goals.
• Demonstrated proficiency in decision-making, with the capability to negotiate and balance priorities across multiple functional departments. Makes timely decisions in the face of risk and uncertainty.

Preferred Industry Experience

• Experience in the medical device industry is highly preferred.
• Experience in the pharmaceutical, biotechnology, or healthcare sectors may be considered.

Additional Skills

• Familiarity with Agile and Scrum methodologies, as well as project management software such as Jira and Microsoft DevOps.
• Meticulous attention to detail.
• Ability to lead meetings with external representatives.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.

Education

• Bachelor's Degree in related field (STEM preferred).
• Master's Degree or equivalent - Preferred.
• PMP/Agile/Scrum Certification - Plus.