Job Description

A contract manufacturing medical device client is looking to hire a Process Development Engineer for a contract role through the end of this year. This person will be part of the functional project engineering group and will be involved in the design, development, documentation and validation of new customer products. This person needs to have experience with the modification of existing 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.

Skills Needed:

• 4-year Bachelor’s Degree
• 5-10 Years experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred
• Strong computer skills, including the MS Office suite and MS Project
• Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
• Technical report preparation and good small group presentation skills

Key Responsibilities:

• Attends and arranges project meetings to discuss current and future design and development initiatives
• Track and communicate issues, status on assigned action items that would affect timelines and budget
• May have involvement in the 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
• Feasibility builds, documentation, and testing
• Equipment selection, process development and documentation
• Device Verification samples and testing

Hourly Rate of $45.00 - $48.00

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