Process Engineer

The Process Engineer will work in a dynamic environment supporting the manufacture and testing of high purity filters with a focus on quality, process control / improvements, electro-mechanical assembly and material handling.

Maintains efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques.Identifies and improves yield loss and scrap opportunities.

Develops and recommends new testing processes and technologies to achieve cost effectiveness and improved product quality.

Establishes operating equipment specifications and improves manufacturing techniques.Inspects performance of machinery, equipment and tools to verify their efficiency and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

Develops manufacturing processes that demonstrate levels of statistical control.Validates new equipment and process changes.

Develops and / or implements systems improvement projects and supports maintenance and production groups in resolving technical and engineering issues.

Provides process on assigned Corrective Action Preventive Action (CAPA).Trains departmental technicians and operators to ensure sufficient expertise exists within the manufacturing work centers.

Reviews capital equipment fabrication activities to ensure manufacturing, construction, installation, and operational testing conform to functional specifications, regulatory safety standards, and user requirements.

Investigates and develops new processes required to improve manufacturing operations and processes.Develops cost estimates, obtains quotes, and generates capital requests to support new processes and capital equipment purchase.

Leads and participates in Equipment and Process Validations activities per Current Good Manufacturing Practices (cGMP) regulations for Medical Device manufacturing.

Ensures that product quality features meet product specifications and comply with process validation requirements.Generates, reviews, and approves engineering, manufacturing and quality procedures necessary to support equipment validation / revalidation, launch, and normal production schedules.

Facilitates training for individuals involved with the operation and maintenance of processes and equipment introduced to the manufacturing department.

Generates engineering procedures and reviews and approves manufacturing standard operating procedures.Develops validation protocols and reports in support of cGMP requirements.

Initiate, reviews / approves change requests, and develops implementation solutions to support operational needs. Who you are : Minimum Qualifications : Bachelors Degree in Electrical Engineering, Mechanical Engineering, Chemical Engineering, or other Engineering discipline.

1+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.

Preferred Qualifications : Masters degree in Electrical, Mechanical or Chemical Engineering. 3+ years of work experience in an FDA regulated medical device manufacturing facility, Pharmaceutical facility, or other regulated industry supporting automated assembly processes, production, and quality department activities.

Instrumentation and PLC code experience.Lean 6 Sigma experience with green or black belt.