Production Optimization Lead

3 weeks ago


Orange, California, United States BioPhase Solutions Full time
Job Title:

We are seeking an experienced Process Engineer to join our client, a leading Orange County medical device company, through BioPhase Solutions.

Compensation: $38-$50/hour, Contract-to-Hire: 3-6 months (possible conversion at end of contract, depending on performance)

About the Role

This position involves leading the design and validation of manufacturing equipment and processes, supporting sustaining manufacturing and operations, and working closely with a cross-functional team to maintain equipment uptime and improve product cost, quality, and safety.

Key Responsibilities:

  • Develop manufacturing and assembly processes that meet Design for Manufacturability requirements for new products.
  • Design, execute, and document process validation protocols to ensure quality and regulatory compliance.
  • Provide expert support to pilot line technicians and engineers, ensuring efficient manufacturing operations and resolving production issues.
  • Identify and develop critical equipment for new product development, maintaining optimal uptime for existing equipment.
  • Purchase and design equipment that meets safety and environmental standards.
  • Collaborate with senior management to address business-related matters and identify opportunities for improvement.
  • Maintain compliance with federal, state, local, and company regulations, policies, and procedures.
  • Lead or participate in troubleshooting activities, process improvements, and root cause analysis of failures.
Requirements

Candidates should possess a Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field. A minimum of 2 years of industry process engineer experience is required, along with expertise in commercial or pilot manufacturing lines, technical report writing, statistical analysis, and data evaluation. Good manufacturing practices and documentation knowledge are also necessary. Strong project management skills and experience are preferred, as well as the ability to travel up to 10% internationally and domestically.



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