Manufacturing Engineer - Medical Device Production at Peregrine Surgical LTD

Doylestown, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Oct, 26

Salary

0.0

Posted On

03 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Auto Cad, Solid Works, ERP, MRP, Lean Manufacturing, ISO 13485, GMP, Design Transfer, Plastic Molding, Process Validation, BOM Generation, Technical Writing

Industry

Medical Equipment Manufacturing

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 Requirements 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

Responsibilities

Develop and implement cost-effective manufacturing processes and documentation for medical device production. Responsible for process improvements, equipment validation, and coordinating the launch of new products from engineering to the production floor.