Process Development Engineer - Enfield, CT
Branch ID: 5246
Pay Rate/Salary: $80,000.00 - $110,000.00
Sr. Process Development Engineers work in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new medical device products, and modification of existing medical device products including 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.
Attends and arranges project meetings to discuss current and future design and development initiatives.
May serve as a primary contact with clients on projects of moderate complexity.
Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.
Provide guidance and direction to coworkers on areas of technical expertise.
Troubleshoot production processes as required.
Evaluate and select appropriate test methods for product requirements
Responsible for the following project inputs:
- Feasibility builds, documentation, and testing,
- Equipment selection,
- Process development and documentation,
- Device Verification samples and testing,
- Operator training,
- Process Failure Mode Effects Analysis,
- Clinical builds,
- Process Validation.
- Involvement in the full design, development, and validation requirements of projects, including:
- 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
- Manufacturing transfer and support of existing product lines as applicable.
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.
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.
#LI-CW1, #medicaldevices, #engineering
A BachelorÃ¢â¬â¢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. 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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Process Development Engineer
City, State or Zip Code: Enfield, CT
Position Type: Direct Hire Position
Date Posted: 9/12/2018