Kforce Senior Medical Device Project Manager in Irvine, California

Kforce has a client seeking a Senior Medical Device Project Manager in Irvine, CA. The Sr. Project Manager is responsible for the overall direction, coordination, implementation, execution, control and completion of clinical and molecular diagnostics instrument development projects ensuring consistency with company strategy, commitments and goals. Tasks and Responsibilities:

  • Lead the planning and implementation of instrument development projects

  • Facilitate the definition of project plan, project scope, project schedule, project budget, milestones goals and deliverables

  • Manage and deliver a DHF compliant with BIT R&D Process and 21 CFR Part 820

  • Act as main contact with client during all development phase

  • Define project tasks and resource requirements

  • Develop full scale project plans and project budget

  • Monitoring and reporting project staff, budget and resources allocation

  • Plan, schedule and manage project timelines

  • Track project deliverables using appropriate tools and metrics

  • Provide direction and support to project team

  • Ensure and maintain development process according to ISO and FDA 21 CFR 820 requirements

  • Constantly monitor and report on schedule and budget of the project to management

  • Qualifications in project management or equivalent - minimum 6 years related experience

  • Scientific or engineering degree

  • Knowledge of both theoretical and practical aspects of project management with PMP Certification

  • Knowledge and experience in IVD Instrument development and engineering projects

  • Proven experience in project management

  • Proven experience in client management

  • Proven experience in risk management

  • Outstanding communication skills at all levels of an organization

  • Excellent written and verbal communication and presentation skills with the ability to articulate ideas and concepts into practical solutions

  • Aptitude for conflict resolution, negotiation and creating positive outcomes

  • Goal orientated - able to set, reach and exceed goals

  • Creative and persistent problem solver; excellent analytical and thinking skills with a highly refined work ethic who is able to work independently or as part of a team

  • Results and goal oriented, competitive and driven to succeed with unquestionable integrity

  • Maintains a steady focus on objectives and tasks - ability to plan and organize activities autonomously

  • Successful project transfer to production of equivalent size/complexity systems

  • Self-confident, highly organized, detail oriented, high energy with excellent time management and planning skills

  • Demonstrated positive interpersonal skills with the flexibility and adaptability to relate to and collaborate with people at all levels of organization and work well with a diverse employee group

  • Proven capability to manage to a budget

  • Positive attitude and desire to succeed

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.Compensation Type:Years