R&d Engineer Iii

BD (Becton, Dickinson, and Company)

Tempe, AZ, USA
Fully remote
Bachelor's degree in engineering
6 years medical device experience
Fda qsr and iso regulatory knowledge
This role involves executing design validation remediation for legacy product families to meet current regulatory expectations

Job Summary

  • This role involves executing design validation remediation for legacy product families to meet current regulatory expectations.
  • The position requires collaborating with Regulatory Affairs and Systems Engineering to ensure risk-retiring activities aligned with global standards.
  • Candidates must be willing to travel up to 10% based on business needs and work a minimum of 4 days in-office per week.

Matching Summary

This role involves executing design validation remediation for legacy product families to meet current regulatory expectations.

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering
  • 6 years medical device experience
  • FDA QSR and ISO regulatory knowledge
  • Design validation remediation execution
  • Risk documentation and traceability maintenance

Nice-to-have

  • Six Sigma or Design for Six Sigma training
  • C/C++ embedded systems software experience
  • Solidworks CAD proficiency
  • Cross-functional team leadership skills
  • Statistical software Minitab proficiency

Key Requirements

  • Bachelor's Degree in Electrical, Mechanical, Biomedical, or related engineering field
  • Minimum 6 years related work experience in medical device development
  • Proficiency in IEC 60601 standards and cGMP/GLP knowledge

Work Rights

Not specified

Tailored Resume

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