US_East | Mechanical & Physical Engineer_L1 - Milwaukee - Expedite Technology Solutions LLC

Description

"Possible 3 Month CTH | No Fees | Do Not Re-Post| Confidential


TMR ID:
3WT06D

Role:
Supplier Quality & Design Engineer

Work location:
Waukesha, WI

Background and Meet and Greet:

MANDATORY

We are seeking someone with strong design experience, specifically with proven capability in managing end to end design change projects from a technical standpoint-not just handling the QMS aspects.

The candidate must understand the design being transferred, be able to interpret critical design specifications, and have the ability to validate the design in the lab or MR bays to ensure requirements are met without introducing system level issues.

In addition, the candidate should be prepared to address any ATE related questions if the transfer includes new ATE development.

we are looking someone with solid electrical engineering background in Milwaukee.

Job Description:
"

• Develop qualification plans for supplier transfer projects and complete associated verification testing.
• Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).

"

UPDATE 01/12:
We received an update from client that the focus is more on electrical background.

Key Responsibilities:
"

• Collaborate effectively within engineering and cross-functional teams.
• Pull together design packages including drawings, specifications, and Bill of Material (BOM)
• Work with suppliers to understand requirements and answer technical questions
• Drive design changes (ECOs) to add alternate supplier or change the approved supplier
• Drive verification of transferred items and First Article Inspections (FAIRs)
• Partner with Modality engineers to understand scope and impact of the transfer "

What are the Mandatory skills and skill proficiencies required for this position?
"

• Background in Electrical or Mechanical Engineering (mix of Mechanical& Electrical Engineers ideal).
• Solid understanding of Medical Device Quality Management System (QMS) processes, with hands-on experience.
• Proven experience managing end-to-end design change projects.
• Electrical Engineering background, preferably with medical device knowledge
• Design Change experience (Inputs, Requirements, Verification, Transfer)
• Ability to read and interpret engineering specifications, drawings, and BOMs

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The following details must accompany your submission:

First Name, Middle name, and Last Name:

City and State:
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Rate:

Availability:

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Hiring Status:
Soemia Pineda - ERM
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• North America

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