R&d Engineer Iii

Hi Tech IT - An Initiative to Digitise

Tempe, Arizona, United States
Fully remote
Design validation remediation
Regulatory requirements
Risk documentation
Execute all facets of design validation remediation for legacy product families, including planning, documentation, and testing

Job Summary

  • Execute all facets of design validation remediation for legacy product families, including planning, documentation, and testing.
  • Collaborate with Regulatory Affairs and Systems Engineering to ensure design validation activities are thorough, risk-retiring, and aligned with global regulatory requirements.
  • BD prioritizes on-site collaboration to foster creativity, innovation, and effective problem-solving, requiring a minimum of 4 days of in-office presence per week.

Matching Summary

Execute all facets of design validation remediation for legacy product families, including planning, documentation, and testing.

Skills & Requirements

Must-have

  • Design validation remediation
  • Regulatory requirements
  • Risk documentation
  • Verification and validation protocols
  • Test method development
  • IEC 60601 standards

Nice-to-have

  • Cross-functional collaboration
  • Influence without authority
  • Project/task management
  • Six Sigma or Design for Six Sigma
  • Process validation (IQ, OQ and PQ)

Key Requirements

  • Bachelor's Degree in Engineering
  • Minimum of 6 years' related work experience
  • Medical device development experience
  • FDA/QSR and ISO environment experience
  • Proficient in statistical software (Minitab)
  • Proficient with modern CAD (Solidworks)
  • Experience in software/firmware development

Work Rights

Not specified

Tailored Resume

Cover Letter