Manufacturing Engineer - Medical Device Production

The manufacturing engineer position develops and implements optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards; recommends and implements improvements to production processes, methods and controls; coordinates manufacturing launch for new or revised products.

Essential Functions

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Generate manufacturing documentation for new products. To include BOM, routers, drawing.
• Update current manufacturing work instructions, drawings, package labeling, and test procedures.
• Develop process improvements, generate new tooling and fixtures
• Implement Lean improvements
• Review and update technical files and design history files
• Write, review and sign all engineering documentation
• Train manufacturing personnel as part of introducing new products/processes from the engineering phase to the production floor.
• Responsible for generation documentation and maintenance of all validation documentation for equipment and production methods.
• Assist in product registrations in foreign countries.
• Support manufacturing, documentation and quality personnel in ISO 13485, GMP controlled environment.
• Analyze existing manufacturing processes, identify and implement process improvements.
• Manage the Preventative Maintenance (PM) system
• Troubleshooting and problem solving
• Other duties as necessary

Experience

• Must have a four-year degree in engineering, mechanical engineering preferred.
• Minimum of 4-5 years related experience.
• Must have worked in a manufacturing environment with some experience with product and/or process development.
• A mechanical background is necessary.
• Auto Cad, Solid Works, ERP or MRP experience is required.
• Medical device manufacturing experience desired. Design Transfer and plastic/molding experience.
• Must be proficient in using Microsoft Office.

Preferred Education and Experience

• Master’s Degree in a technical area.
• 5-10 years related experience