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. The successful candidate will be an enthusiastic team player with high energy and strong engineering skills.
- 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:
- Bachelors of Science Degree in Electrical, Mechanical or Chemical Engineering (or closely related field) and 1+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.
- Alternatively, Employer is willing to accept a Master’s degree in Electrical, Mechanical or Chemical Engineering (or closely related field) and 1+ 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 knowledge a plus
- Lean 6 Sigma experience with green or black belt preferred.