The Project Manager will be responsible for the overall direction, coordination, implementation, execution, control and completion of assigned projects ensuring consistency with company strategy, commitments and goals. This includes securing appropriate internal and external resources and coordinating the efforts of team members and third-party contractors or consultants in order to deliver projects according to plan. The Project Manager is accountable for overall manufacturing engineering leadership in delivery of assigned projects. The Project Manager will report to the Manufacturing Engineering manager for ASP WW. The Project Manager will be expected to mentor Project Engineers and to further improve the Manufacturing Engineering team’s project management processes and capabilities. The Project Manager is responsible for leading cross functional teams in the achievement of project objectives through management of supply chain and manufacturing activities. They develop project scope and objectives, establish and track critical milestones, timelines and contingency plans. They follow up throughout project process to ensure project goals are achieved.

The Project Manager provides overall Process Engineering Technical contributions, guides and mentors team members in delivery of robust solutions based on sound technical / engineering decisions. The Project Manager assures that assigned projects adhere to company policies and standards to deliver solutions that are compliant to industry / agency requirements.

The Project Manager is expected to lead multiple projects simultaneously depending on project scope. Projects assigned to the Project Manager will generally be of significant complexity but will also include lower complexity projects depending on our project priorities. Projects types vary and include but are not limited to: New and Modified Product Introductions, New and modified business processes (example: Preventative Maintenance & Calibration systems, Process / Product transfers, CAPA Management), New component introduction, New Equipment, Process Characterization projects, Validation Projects.

As deemed relevant the development and periodic review of standard operating procedures and specifications, testing procedures and specifications, documentation revision control, non-conformance reports, failure investigations, change orders, corrective action/preventive action documentation, and manufacturing project scheduling and coordination is expected.

Qualifications

A minimum of a BS Engineering Degree or equivalent and at least 8+ years of related engineering project management experience is required. An advanced engineering degree and / or MBA is preferred. Demonstrated capital and expense management experience is preferred. Previous experience in process development, characterization, and equipment qualification in the medical device industry is required. Previous experience in project management of multi-discipline teams required. The successful candidate will possess excellent technical process and product knowledge, excellent process engineering skills, strong financial acumen, and the ability to take an enterprise view of company objectives. Six-Sigma certification is preferred, PMP and / or FPX certification preferred. Experience in New Product Introduction and Technology Transfer desired. Experienced with FDA and other regulatory guidance is required. Proficiency in Microsoft MS Office is required; experience using MS Project and Auto CAD is preferred. This position is based in Irvine, CA and may require up to 20% travel.

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Primary Location: North America-United States-California-Irvine
Organization: Ethicon Inc. (6045)
Job Function: Process Engineering

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