Orange County Metro Area, California
The primary scope of this role is to ensure production attainment through technical troubleshooting, process controls, equipment maintenance, and technician support.
Responsibilities will include but are not limited to the following:
Process ownership to ensure manufacturing processes remain in a validated state and yields products that adhere to all specifications, requirements, and controls
Technical ownership to perform formal and/or informal root cause investigation and corrective action of product, equipment, material, or process mon-conformances, anomalies, observations, etc.
Technician support- Availability to technicians to answer technical questions, provide guidance, and receive feedback.
Identifies and implements initiatives that improve customer facing quality, reliability, or cost reduction.
Identifies and implements initiatives that improve manufacturing yield, cycle time, supplier performance, flow, operator safety & ergonomics, process simplicity, clarity, repeatability, and robustness
Provides on-going oversight and assurance that production equipment is properly maintained, safe, and in a state of control at all times
Serves as a subject matter expert at specific product development phases for DFM, process development, and capability assessment reviews.
Bachelor of Science degree in Engineering (Mechanical or Industrial preferred) or scientific field
Minimum 1+ years experience in an engineering role within Medical Device Operations or Manufacturing environment