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 Experience5+ years of engineering experience (preferably in medical devices)Demonstrated ability to utilize statistical tools and computer analysisLocation : 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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