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Design Assurance Engineer
Design Assurance EngineerZipRecruiter • Saint Paul, MN, US
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Design Assurance Engineer

Design Assurance Engineer

ZipRecruiter • Saint Paul, MN, US
3 days ago
Job type
  • Full-time
Job description

Overview

Design Assurance engineer to represent the Quality function on a product development team. This engineer would be a key contributor to risk management and design verification planning and execution. Secondarily, this position would also provide support for supplier management and material quality activities.

Responsibilities

  • Work with the product development team(s) in conducting risk analysis activities such as Design FMEAs, Process FMEAs, Hazard Analysis, and User Risk Analysis.
  • Manage tracability of design requirements through risk mitigation and design verification
  • Technical writing and critical review of design verification plans, procedures, test protocols and reports.
  • Critical review of design and process documents and records such as procedures, specifications, drawings and various Design History File records
  • Lead key equipment qualification efforts
  • Lead supplier management activities
  • Review and evaluate non-conforming materials.
  • Work with vendors to correct material non-conformances
  • Generate inspection procedures for both incoming parts and on-site production.
  • Review manufacturing documentation for accuracy and clarity.
  • Contribute to process validation activities
  • Proficient knowledge and use of applicable industry standards specifically, ISO 13485 for Quality Systems, and ISO 14971 for Risk Management
  • Proficient in MS Office Suite including but not limited to MS Outlook, MS Word MS Excel, MS PowerPoint.

Additional Job Expectations

  • Being aligned with team goals and supportive in a team environment
  • Sound communication in collaborations with other company functions (written and verbal)
  • Using good judgment when confronted with choices
  • Being organized, thorough in prioritizing and generating work products
  • Being both proactive and professional
  • Education and Experience

  • BS in Mechanical Engineering or a related field
  • 5+ years of Design Assurance in Life Sciences Industry; IV D medical device environment a plus
  • Experience with statistical methods and terminology
  • Demonstrated structured problem-solving skills
  • J-18808-Ljbffr

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    Design Assurance Engineer • Saint Paul, MN, US

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