Manufacturing Engineer - Medical Device Production
Peregrine Surgical LTD
Job Description
Job Description
Description:
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
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