R&D Project Manager - Onsite

MillenniumSoft Inc; 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

Job Title: R&D Project Manager

Duration: 12 months contract.

Location: Irvine, CA

• 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 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.