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Staff Engineer(5 years of design development medical device experience)
Staff Engineer(5 years of design development medical device experience)MillenniumSoft Inc • Sandy, UT, US
Staff Engineer(5 years of design development medical device experience)

Staff Engineer(5 years of design development medical device experience)

MillenniumSoft Inc • Sandy, UT, US
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Job Overview

Join MillenniumSoft Inc as a Staff Engineer with 5+ years of design development medical device experience.

Job Description

This position will provide project leadership in DHF remediation activities for Class I and Class II medical devices. A minimum of 5+ years of design development medical device experience is required.

Key responsibilities include :

  • Review of existing DHFs and additional DHF Assessments to determine final gaps per client Quality System
  • Review of Applicable Standards and EU MDR requirements
  • Establish Remediation Plans for DHF & EU MDR deliverables
  • Development of Traceability Documents
  • Quality Plan closures as appropriate
  • Facilitation of Packaging, Sterilization, and Biocompatibility testing
  • Provide solid technical skill and engineering support for design and development activities
  • Support current products in terms of quality, manufacturing, supply continuity and cost improvement

Qualifications & Skills

  • BS degree in engineering (Mechanical or Biomedical Engineering preferred)
  • Design Control medical Device Experience
  • 5+ years of engineering experience (preferably in medical devices)
  • Demonstrated ability to utilize statistical tools and computer analysis
  • Location : Sandy, UT

    Duration : 12 Months Contract

    Total Hours / week : 40.00

    Shift : 1st shift

    MilleenniumSoft Inc is an equal opportunities employer and welcomes applications from all qualified candidates.

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    Of Staff Development • Sandy, UT, US

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