BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Process Engineer to work for a leading Orange County area medical device company.
**No C2C**
Pay Rate: $33-45/hour
Contract: 6+ months (possible conversion, depending on experience)
Summary
The Process Engineer will lead multiple aspects of manufacturing equipment and process design and validation. This position will be responsible for supporting the sustaining manufacturing and operations and working closely with a cross functional team while maintaining equipment uptime and improving upon product cost, quality, and safety.
Responsibilities
- Responsible for developing manufacturing and assembly processes consistent with Design for Manufacturability for new product introductions.
- Designs, executes and documents process validation protocols in support of quality and regulatory requirements.
- Provides 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.
- Identifies and develops the crucial equipment related to new product development and maintains appropriate uptime for current equipment.
- Assists pilot line technicians and engineers on manufacturing problems. Purchases and designs equipment that meets safety and environmental requirements.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for ensuring 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.
- Assist with other responsibilities and/or projects as the need arises.
Experience/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, required.