Manufacturing Project Manager

Overview:

This position is responsible for providing manufacturing engineering project management by helping create/lead a high-performance culture that supports the growth of existing product offerings as well as new product introductions. The role will help drive and oversee innovative change in manufacturing through process improvement and equipment optimization by proactively challenging existing paradigms.  A key responsibility will be oversight for a facility move.

Only candidates with PM experience from medical/medical device manufacturing companies will be considered!

Responsibilities:

  • Overall project management for relocation of our manufacturing operations to a larger facility in Irvine (4x current size).

  • Provide project management support to the manufacturing engineering group by managing operational strategies.

  • Conducts and serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations to address quality, technical, and manufacturing issues.

  • Applies data analysis techniques including statistical process control and six sigma methodologies to resolve issues that adversely affect manufacturing in the areas of capacity, quality, compliance or cost.

  • Coordinates and provides direction and assistance on resolution of complex issues, compliance issues and potential problems related to planning, operations, quality and R&D.

  • Ensures manufacturing operates in accordance with department SOPs which meet regulatory and cGMP standards.

  • Manages key performance indicators to measure performance and effectiveness.

  • Ensure the skills, capabilities and talents of the manufacturing engineering team are effectively leveraged.

  • Keeps up to date on new developments and technologies and presents on best practice methodologies, procedures, processes and equipment.

QUALIFICATIONS:

  • Only candidates with PM experience from medical/medical device manufacturing companies will be considered!

  • A minimum of a Bachelor’s degree in an Engineering or Science discipline is required; an advanced degree (MS) is desirable.

  • Manufacturing project management, especially with facility relocations.

  • Six Sigma or Lean Manufacturing certification is plus.

  • Previous manufacturing engineering work experience in a medical device manufacturing environment is required.

  • Prior experience in a cGMP environment within the medical device or FDA-regulated industry is required.

  • Experience managing and executing business process changes and change initiatives.

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