Medical Device Process Development Engineer - Enfield, CT
Branch ID: 5246
Pay Rate/Salary: $75,000.00 - $130,000.00
Intermediate Process Development Engineer opportunity in Medical Device Manufacturing for a local candidate in the Enfield, CT area!
The Process Development Engineer works in a project engineering group consisting of multiple engineering disciplines involved in the design, development, documentation and validation of new medical device products, and modification of existing medical device products.
Scope of work includes defining requirements, timelines and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production and preparation for process validation and manufacturing transfer of products to commercialization.
Responsible for the following Medical Device project inputs:
Feasibility builds, documentation and testing
Process development and documentation
Device Verification samples and testing
Process Failure Mode Effects Analysis
Involvement in the full design, development and validation requirements of projects:
Product design and specification creation, including mechanical and electrical components, assemblies and packaging
Materials sourcing and device prototyping
Design verification and validation activities, including data for regulatory submission
Arranges and attends project meetings to discuss current and future design and development initiatives.
Assists with the preparation of proposals and quotations for clients and interfaces to resolve questions in a timely manner.
Assists in preparation and maintaining project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions.
Tracks and communicate project status, plans, issues, timelines, action items, and budgets.
Provides guidance and direction on areas of technical expertise.
Troubleshoots production processes.
Evaluates and selects test methods for product requirements
A Bachelor's degree in an engineering discipline with 5 years of relevant medical device manufacturing experience Must be able to read, write and speak fluent English and have hands on experience in a medical device engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience. Strong computer skills, including the MS Office suite and MS Project. Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents. Strong analytical skills, must be able to obtain and evaluate secondary research information.
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Medical Device Process Development Engineer
City, State or Zip Code: Enfield, CT
Position Type: Direct Hire Position
Date Posted: 10/10/2018