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The Copley Consulting Group

Product Development Engineer / Design Quality Engi

Career Insights for Manufacturing Process Engineer

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Based on Massachusetts data

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What they do

A Manufacturing Process Engineer develops workflow, work station, and equipment improvement recommendations within a company's manufacturing environment. Fine tunes manufacturing processes by researching, designing, modifying, and testing manufacturing methods and equipment. Evaluates manufacturing processes, applies knowledge of product design, fabrication, assembly, tooling, and material.

$105,366 / year median in Massachusetts

-3% projected decline

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Job Description

Our client is currently seeking a Product Development Engineer / Design Quality Engineer. This job will have the following responsibilities: Conduct product design control activities for both new product development and sustaining engineering projects. Support risk management activities, including Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA). Participate in design and process verification/validation activities, including: Design Verification (DV) Design Validation (PV) Software Validation
IQ/OQ/PQ
(Installation Qualification, Operational Qualification, and Performance Qualification) Support Design Engineering in the development and maintenance of: Design History Files (DHF) Technical Files Design specifications Verification and validation documentation
Qualifications & Requirements:
Bachelor's degree in Engineering, Science, or a related technical discipline. Electrical Engineering degree preferred. 3 to 5 years of experience in the design and development of Class II electro-mechanical medical devices. Experience working within FDA-regulated and ISO-compliant medical device environments.