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Development Quality Engineer II

Little Canada, MN 55117

Posted: 09/12/2023 Employment Type: Contract Job Category: Engineering Job Number: 584939 Is job remote?: No Country: United States

Job Description

Target PR Range: 26-50/hr
*Depending on experience

Requisition Description:
This position will support a new product development project and support completion of design control deliverables.  The project is a new development program, following our phase gate process.  Initial work will be related to the Design Input Phase Review, then moving into the Design Selection Phase.  Primary work will include test method validation, writing design verification protocols, coordinating sample builds and testing, analyzing test results, writing design verification reports, updating FMEAs and other risk documentation and maintaining traceability documentation.  This position may also support implementing improvements to design control processes and procedures.

Key Responsibilities:  
•    DQ team member – assigned DQ deliverables to own and complete per design control requirements.
•    Keep track of assigned deliverables.
•    Work collaboratively and cross-functionally to complete the deliverables
•    General DQ tasks:  Risk Management (RMR, dFMEA, uFMEA), Design Verification Testing, Design Validation Testing, Development Test Method Validation and TMV master plan.  For DV/DVal testing, this includes writing protocols, managing test sample builds, coordinating testing with testing technicians, analyzing results and writing reports.
•    Own change orders and release documents through the electronic document management system.

Key Requirements:
1)    New product development experience.
2)    Problem solving and CAPA experience.  Ability to analyze problems and come up with creative solutions.  Lead root cause investigation meetings.
3)    Good communication/leadership skills.  Able to work cross functionally.
4)    Good documentation writing skills.
5)    Testing coordination experience
6)    Protocol development experience.
7)    Report writing experience.
a.    Must have good attention to detail
b.    Able to conduct data analysis and apply statistical technics to data
c.    Be able to clearly document what was done and justify any deviations to the protocol
8)    Helpful Experience:
a.    Experience implementing improvements to design control processes and procedures.
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