Manufacturing Engineering Mgr - Irvine, United States - Clinch

Description

The Manufacturing Engineering Manager leads a team of Engineers responsible for sustaining and optimizing the manufacturing processes and equipment at Bio-Rad's QSD Manufacturing Facility in Irvine, CA.

The ME team is responsible for the selection, qualification, implementation and sustainment of equipment and processes that effectively support manufacturing operations and the site strategic plan.

In addition, Manufacturing Engineering is the custodian of existing processes and is tasked with continuous improvement and risk management activities to ensure the manufacturing operation is effectively supported and maintained.

Responsibilities

Manages a team of 8-12 direct reports comprised of Engineers and Engineer Technicians.
Manages team performance through regular 1:1 meetings and "SMART" objectives that are aligned with site and divisional priorities.
Establishes and maintains

contructive and collaborative relationships with the manufacturing, equipment maintenance, and R&D groups to ensure manufacturing processes are properly characterized, qualified/validated, and maintained in a "validated" state.

Ensures internal customers are supported and their priorities accommodated.
Recognized as an SME with regard to validation and risk management.

Ensures the ME team is effective in establishing qualified processes developed using a "risk-based" approach and are robust and sustainable.

Effectively represents Engineering in Quality/Regulatory and Customer compliance audits.
Supports CAPA/NCMR/Component Complaint Investigations.
Manages team development and EH&S initiatives.
Manages departmental budget.
Qualifications

Bachelor's degree in Engineering (or equivalent) is required. An advanced degree is preferred.
Minimum of 5 years experience managing a team of Engineers in a GMP/ISO regulated manufacturing environment is required.
Demonstrated experience with lean manufacturing principles and process/equipment validation. Six Sigma Certification is desireable.
Experience leading CAPA teams and addressing NCMR-related issues.
Demonstrated track record of effective management within a highly-regulated manufacturing environment.
Knowledge and applied experience with metrology, equipment maintenance, and validation management is required.
Knowledge and experience with SAP is prefrerred.

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