JOBS IN PLASTIC, MEDICAL DEVICE AND PACKAGING

MEDICAL DEVICE PROJECT ENGINEER JOBS

Project Engineer-Medcial Device

Client is a manufacturer of plastic medical device components located in Massachusetts.  Continuing advancement in design and technology have created an immediate need for an experienced Project Engineer to guide the development, production launch, and optimization of clean room molding and assembly operations.  

Responsibilities:

The Project Engineer-Manufacturing and Development will lead and coordinate the development of injection molded plastic medical device products and the processes needed to produce those products.  Duties will include:

• Working closely with Product Design, Tooling, and Customer in early concept development to provide  technical input on Design for Manufacture (DFM), Manufacturing Process Issues, Tooling and Equipment Requirements and Project Cost Estimates.
• Development of Prototype Tooling and production of required prototypes. 
• Management of prototype testing and evaluations leading to customer approval.
• Complete FMEA.
• Selection of tooling vendors and supervision of mold/tool development process including design review, mold build, and mold trials.
• Provide technical support in the selection and/or purchase of capital equipment, scheduling of production launch, and development of process or assembly systems.
• Full responsibility for driving the validation process (IQ, OQ, PQ) including documentation and obtaining customer approvals.
• Completion and presentation of regular Project Reports using Microsoft Project.

Requirements include:

• BS Plastics, Mechanical or other Engineering/Technology degree.
• Three or more years of specific experience in plastic injection molding of medical device products in ISO, FDA/GMP compliant environments.  Clean Room Molding and Assembly experience is preferred.
• Specific knowledge of plastic tool design and construction, prototyping techniques, DFM, FMEA, development of molding processes, mold trial management and production launch operations.
• Demonstrated proficiency with Microsoft Project and/or other Project Management techniques.
• Demonstrated proficiency in IQ, OQ, PQ validation processes in FDA Regulated manufacturing.
• Well developed communication skills (Written and Interpersonal)

Compensation:

Company provides a highly competitive starting salary and opportunities for exceptional career growth as the company expands over the next several years.  In addition, the company provides Medical, Dental, Life and Disability insurance and a generous 401k program. 

Apply Now!

Please email your resume in Word Format to Roger Aistrup at: jobs@allanjamesassociates.com