Process Engineer

May serve as a primary contact with clients on projects of low to moderate complexity.

Assist with preparation of proposals and quotations for clients

Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.

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