Process Engineer

1 day ago


Orange, California, United States BioPhase Solutions Full time
Job Overview

BioPhase Solutions is seeking a highly skilled Process Engineer to join our team in Orange County, California. As a Process Engineer, you will play a critical role in leading multiple aspects of manufacturing equipment and process design and validation.

Key Responsibilities
  • Develop and implement manufacturing and assembly processes consistent with Design for Manufacturability for new product introductions.
  • Design, execute, and document process validation protocols in support of quality and regulatory requirements.
  • Provide on-demand pilot line support, managing manufacturing metrics (yields, cycle times, capacity, bottlenecks), ensuring adherence to quality and compliance procedures, identifying and implementing continuous process improvements, deploying new fixture and tooling, and supporting manufacturing documentation updates.
  • Identify and develop crucial equipment related to new product development and maintain appropriate uptime for current equipment.
  • Assist pilot line technicians and engineers on manufacturing problems. Purchase and design equipment that meets safety and environmental requirements.
  • Communicate business-related issues or opportunities to next management level.
  • Ensure personnel and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
  • Lead or support troubleshooting activities and process improvements. Perform root cause analysis of failures. Work on special projects as requested by management.
Requirements
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field is required.
  • Minimum of 2 years of industry process engineer experience is required.
  • Experience with commercial or pilot manufacturing lines, technical report writing, statistical analysis, and data evaluation is required.
  • Knowledge of good manufacturing practices and documentation is required.
  • Strong Project Management experience and skills are preferred.
  • Ability to travel up to 10%, international and domestic, is required.

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