CyberCoders Project Manager - IVD Development in Irvine, California

Project Manager - IVD Development Project Manager - IVD Development - Skills Required - Project Management, IVD Development Projects, ISO 13485

If you are a Project Manager with experience, please read on!

We are the leading resource for turnkey development and manufacturing of IVD instrumentation and complex life science products. Our senior staff members have an average of fifteen years experience in the industry, each with a long history of successfully developing and manufacturing medical devices, in vitro diagnostic instruments and bioresearch platforms.

What You Will Be Doing

  • 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

  • Act as main contact with customer and internal stakeholders during all development phases

  • Define project tasks and resource requirements

  • Collaborate closely with industrial engineering, key-account management and customer service

  • Develop full scale project plans and project budget

  • Monitoring and reporting project staff, budget and resources allocation

  • Plan and schedule project timelines

  • Track project deliverables using appropriate tools and metrics

  • Provide leadership, direction and support to project team

  • Hands on development work

  • Ensure and maintain development process according to ISO 13485 and FDA 21 CFR 820 requirements

  • Constantly monitor and report on progress of the project to management

  • Present reports defining project progress, problems and solutions

  • Document, implement and manage project changes and interventions to achieve project outputs

  • Project evaluations and assessment of results

What You Need for this Position

  • Qualifications in project management or equivalent - minimum 4 years related experience

  • Certification in advanced project management is preferred

  • Scientific or engineering degree

  • Knowledge of both theoretical and practical aspects of project management

  • Knowledge and experience in IVD and/or medical development projects

  • Proven experience in project management

  • Proven experience in project budget controlling

  • 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 and driven to succeed with unquestionable integrity

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

  • 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

  • Positive attitude and desire to succeed

  • Highly organized - Excellent follow through and follow up skills; results and delivery oriented

  • Able to multi-task a variety of duties and work requests

  • Self-motivated and works well under pressure with changing priorities and a workload

  • Team player with very good collaboration skills, fostering knowledge sharing with team members

  • Exceptional communication and documentation skills

What's In It for You

  • Competitive base salary

  • 10% bonus

  • 401k, PTO, and excellent benefits

  • Fun work environment and career growth

So, if you are a Project Manager with experience, please apply today!

Applicants must be authorized to work in the U.S.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Project Manager - IVD Development CA-Irvine GC3-1467935