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Process Development Engineer
Location:
US-MN-Saint Paul
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Role: Development Process Engineer

Location: St. Paul, MN

Duration: 12 Months on W2

Process Development

Design Support - Establish processes based on product and print requirements. Evaluate process and design alternatives based on Design for Manufacturability principles.

Process Optimization - Design and qualify equipment, fixtures, and tooling in order to understand process input and output relations via technical reports and Test Method Validations (TMV).

Process Validation - Protocol and report writing, as well as execution of IQ/OQ/PQs, and PPQs.

Root Cause Analysis and Troubleshooting - Resolves and/or facilitates the resolution of problems including identifying causes and implementing solutions to prevent re-occurrence.

Risk Management - Perform risk management activities using Failure Mode and Effect Analysis methodology (e.g. dFMEA, pFMEA).

Production support - Provide technical support for manufacturing processes and equipment to ensure high quality and yield.

Project Management:

Lead and interact with functional groups (e.g. research and development, quality, manufacturing, supply chain) as necessary to define work breakdown to achieve project goals related to schedule, performance, and cost.

Plan and conduct small to medium size projects. Coordinates and monitors activities. Makes judgments regarding quality of implementation within discipline.

Manage program compliance with internal and external standards (e.g. Design Control, Process Validation, and Process Control Plans).

Understand work environment issues (e.g. OSHA regulations, etc.).

Compliance:

Bachelor of Science in Engineering

2-5 years engineering experience, prior medical device experience preferred.

Experience and Education:

Experience developing manufacturing processes, technologies, and Design for Manufacturability (DFM).

Experience with statistical analysis (e.g. Gage R&R, Cpk, SPC, DOE), Six Sigma certification and Minitab experience preferred.

Ability to work within a team, and as an individual contributor in a fast-paced environment.

Ability to leverage and/or engage others to accomplish tasks.

Multitasks, prioritizes, and meets deadlines in a timely manner.

Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.

Strong organizational skills and attention to detail.

Regards,

Norman Wick | Technical Recruiter

Intellect Inc

Desk: 551 314 6454 Ex: 152

Email: : Norman@intellectt.com

Website: (link removed)

Intellectt INC

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