Process Engineer / Manufacturing (Medical Devices)

Responsibilities   

·         Support Operations team with Setup and Operation thin metal stamping and forming processes.   

·         Develop Work Instructions to standardize setup and operations   

·         Identify and implement improvements in the existing equipment/tooling in assigned area.   

·         Support new equipment / process implementation and transfer of equipment/processes.   

·         Lead equipment maintenance efforts including, developing preventative maintenance activities and intervals.   

·         Support Design for Assembly analysis.   

·         Risk Analysis Activities   

·         Product Validation Activities   

·         Continuous improvement Activities   

·         Support tooling maintenance and repair activities   

·         Special Requirements or Call outs: (ex: standing for long hours, lifting requirements, etc.)   

Other Requirements (Specialized):   

·         Metals Processing:   

·         Stainless steel film stamping   

·         Stainless forming and winding   

·         Custom Built Equipment   

·         Electro-Mechanical troubleshooting and improvement of systems in production   

·         Precision alignment or adjustment +/- 0.00X” of mechanical assembly systems   

Educational Qualifications:   

·         Bachelor’s Degree in Engineering discipline or equivalent tool and die, metal stamping, or metal forming is required.   

·         Experience requirements: (ex: entry level, 5 years, etc.)   

Required Knowledge, Skills, and Abilities:   

·         3 to 5 years’ experience in medical device manufacturing environment.   

·         Relies on limited experience and judgment to plan and accomplish goals.   

·         Lean manufacturing and advanced statistical analysis.   

·         CAD / Drafting Experience. Solidworks   

·         Computer literacy, knowledge of Microsoft Windows, Microsoft Office.   

·         Understanding of Bill of Material (BOM).   

·         Capable of creating drawings, manuals, and engineering specifications.   

·         Self-starter with enthusiasm and ability to work in a team environment.   

·         Familiarity with ISO standards, GMP, and OSHA regulations.   

·         New Process Development   

·         PFMEA Development Leader   

·         Process DOE development and execution   

·         Process Validations.             

Other Requirements (Specialized):   

·         Metals Processing:   

·         Stainless steel film stamping   

·         Stainless forming and winding   

·         Custom Built Equipment   

·         Electro-Mechanical troubleshooting and improvement of systems in production   

·         Precision alignment or adjustment +/- 0.00X” of mechanical assembly systems