Senior Design Engineer

6 days ago


Sandy, United States MILLENNIUMSOFT Full time
Job Summary

We are seeking a highly skilled Senior Design Engineer to lead our medical device development team. As a key member of our team, you will be responsible for providing project leadership in DHF remediation activities for Class I and Class II medical devices.

Key Responsibilities
  • Review existing DHFs and conduct additional DHF assessments to determine final gaps per client Quality System
  • Review applicable standards and EU MDR requirements
  • Establish remediation plans for DHF & EU MDR deliverables
  • Develop traceability documents, including design verification protocols/reports and risk management plans
  • Facilitate packaging, sterilization, and biocompatibility testing through client Centers of Excellence and Resources
  • Provide technical support for design and development activities for new and existing products
  • Support current products in terms of quality, manufacturing, supply continuity, and cost improvement
  • Participate in executing technical and/or cross-functional project work
  • Contribute to a culture of innovation by generating novel concepts for new products and enhancements to current product performance
Requirements
  • 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
About MillenniumSoft

MillenniumSoft is a leading provider of medical device development solutions. We are committed to delivering high-quality products that meet the needs of our clients and customers.



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