Associate Failure Analysis Engineer (on-site)

Insulet Corporation

Massachusetts, US
On-site
Bachelor's degree in engineering or scientific discipline
Root cause analysis and hypothesis development
Ms excel proficiency for chart creation
Insulet Corporation is seeking an Associate Failure Analysis Engineer to join their Quality Department in Massachusetts. The role involves conducting post-market investigations of FDA-approved medical devices and requires strong organizational skills, attention to detail, and collaboration with cross-functional teams

Job Summary

  • The role involves conducting post-market investigations of FDA-approved medical devices to ensure compliance with quality standards.
  • Candidates will perform deep dive investigations, generate trend charts, and assist in FDA and ISO 13485 inspections.
  • The position requires applying Lean Six Sigma methodology to evaluate process flows and improve safety and efficiency.

Matching Summary

Match Score: 85

Insulet Corporation is seeking an Associate Failure Analysis Engineer to join their Quality Department in Massachusetts. The role involves conducting post-market investigations of FDA-approved medical devices and requires strong organizational skills, attention to detail, and collaboration with cross-functional teams.

Skills & Requirements

Must-have

  • Bachelor's Degree in engineering or scientific discipline
  • Root cause analysis and hypothesis development
  • MS Excel proficiency for chart creation

Nice-to-have

  • Lean Six Sigma methodology experience
  • Prior regulated industry background
  • Strong technical writing skills

Key Requirements

  • Minimum Bachelor's Degree in engineering or science
  • Preferred 2 years in Quality related function
  • Experience with QSR and/or ISO 13485

Work Rights

Not specified

Tailored Resume

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