Engineering Project Manager

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Location: Irvine, CA US
Job Category: Research and Development
Position Description
Engineering Project Manager

As an Engineering Project Manager you will lead and drive the development of new medical device development programs and coordinate cross-functional teams throughout the project life cycle, from concept development to world-wide launch. Collaborate with internal cross functional resources and external partners (such as suppliers, vendors, testing labs and services) to properly staff the project and manage project risk.

In particular you can expect to:

  • Lead and integrate cross-functional teams and manage deliverables in a matrix organization.
  • Work within budget, schedule, and scope, while managing risk, and ensuring adherence to established processes, methodologies, and design controls.
  • Work with engineers, clinical representatives, regulatory affairs, and quality, finance, manufacturing and supply chain managers to achieve goals to a strict timeline.
  • Identify and implement solutions to improve tracking, planning and collaboration.
  • Ensure effective, accurate and timely communication across functional areas.
  • Work with the team leaders to identify and resolve any team and individual performance issues.
  • Manage and coordinate the activities of a multi-disciplined project from concept to production.
  • Create and maintain schedules that predict and meet milestones to track progress.
  • Review analyses of activities, costs, operations, and forecast data to determine program progress toward stated goals and objectives. Assist in Risk Analyses, Cost Estimates, ROI, Resource management, Margins, and Scope-creep Avoidance.
  • Communicate with Senior Management to review progress, program risk reduction, and issue resolution.

You will have the opportunity to:

  • Improve patient outcomes
  • Meaningfully impact the company‚Äôs short-term and long-term success
  • Work closely with executives across the organization
  • Grow your role as you see fit
  • Learn everything there is to know about respiratory medical device manufacturing
  • Create an inspiring workplace

To be successful, you will need:

  • At least 4 years of related work experience in medical device and/or drug development and project management within the device/pharmaceutical industry, or reasonable combination in project management.
  • Ability to communicate effectively and gain cooperation of others to effectively facilitate cross-functional meetings and discussions.
  • Direct work experience in project management capacity, demonstrating success in large project/program management role including development and deployment, preferably healthcare, or closely field.
  • Proficient in project management software to create accurate project schedules and resource loading.
  • Knowledge of both theoretical and practical aspects of project management.
  • Global product development and team management experience is a plus.
  • Strong familiarity with the integration of requirements and deliverables associated with Design Controls (21CFR820.30) into the product development process.
  • Expert planning and organizing skills, including attention to detail and multi-tasking skills.
  • Proven track record of team leadership demonstrating a balance between delegation and a hands-on, can-do attitude.

Some Logistics:

  • The current office is based in Yorba Linda however we will be moving to the Irvine area. Once property is identified in Irvine, this position will relocate to the new space based in the Irvine area.

Irvine, CA

Full time
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