Process Development Engineer

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