Manufacturing Engineer - Medical Device Production

Peregrine Surgical LTD•Doylestown, PA

About The Position

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.

Requirements

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.
Must be proficient in using Microsoft Office.

Nice To Haves

Medical device manufacturing experience desired.
Design Transfer and plastic/molding experience.

Responsibilities

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