Job Description:
- The Process Engineer participates in Operations, and Engineering initiatives. Directly responsible for supporting assigned manufacturing processes along with supporting new implementations. This position will be working closely with all aspects of the business as cross functional support.
- 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
- 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
- Bachelor's Degree in Engineering discipline or equivalent tool and die, metal stamping, or metal forming is required.
- 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