Staff Engineer; of design development medical device

Job Overview

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

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

• 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

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