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Senior Design Quality Engineer
Senior Design Quality EngineerSwitchback Medical • Minneapolis, MN, US
Senior Design Quality Engineer

Senior Design Quality Engineer

Switchback Medical • Minneapolis, MN, US
[job_card.30_days_ago]
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  • [job_card.full_time]
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Job Description

Job Description

Essential Duties and Responsibilities (but not limited to) :

  • Own creation and implementation of all design control deliverables
  • Lead on-time Design Verification and Design Validation (and support Process Validation IQ / OQ / PQ / PPQ) planning & execution
  • Actively participate in and contribute to core team and customer facing meetings
  • Drive meaningful translation of User requirements into discrete, objective, measurable, verifiable, and traceable Product requirements
  • Oversee risk management activities throughout the device life cycle - from product concept through post launch
  • Create accurate and repeatable test & inspection methods
  • Support creation and execution of biocompatibility and sterilization qualifications
  • Analyze data and prepare product test reports
  • Oversee content of the Design History File, its completeness and integrity
  • Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plans, First Article Inspections and supplier process qualifications
  • Support supplier management activities and external audits
  • Support external audit and certification efforts conducted by customers and regulatory bodies
  • Support manufacturing lines by resolving components issues or other manufacturing barriers in a timely manner.
  • Oversee and approve document change requests, non-conformances, deviations and special work order processes
  • Lead root cause analysis and resolution activities
  • Review and approve equipment specifications and qualification
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Senior Design Engineer • Minneapolis, MN, US

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