Sr Engineer Risk Management

Medline Industries LP

Base: $92,000.00 - $138,000.00 annual; bonus/equit...
Not specified
Bachelor of science in engineering or biology
4 years qa/qe experience in cgmp device environment
2 years direct risk management experience for fda regulated products
Medline Industries LP is seeking a Senior Engineer in Risk Management responsible for developing and overseeing risk controls related to medical devices, cosmetics, and OTC drugs. The ideal candidate will have significant experience in quality assurance and risk management within FDA-regulated environments, with strong project management skills

Job Summary

  • This role serves as the senior lead contributor for analyzing quality data and major events to ensure global risk control for medical devices and pharmaceuticals.
  • The incumbent will evaluate risks and act as an approver for critical processes including Failure Mode Effect Analysis, Medical Device Reporting, and Recalls.
  • Medline offers a competitive total rewards package including health insurance, 401(k) contributions, and paid time off for eligible employees.

Matching Summary

Match Score: 85

Medline Industries LP is seeking a Senior Engineer in Risk Management responsible for developing and overseeing risk controls related to medical devices, cosmetics, and OTC drugs. The ideal candidate will have significant experience in quality assurance and risk management within FDA-regulated environments, with strong project management skills.

Salary

Base: $92,000.00 - $138,000.00 Annual; Bonus/Equity: Bonus and/or incentive eligible; Benefits: Health insurance, life/disability, 401(k), PTO

Skills & Requirements

Must-have

  • Bachelor of Science in Engineering or Biology
  • 4 years QA/QE experience in cGMP Device environment
  • 2 years direct risk management experience for FDA regulated products
  • Experience with FMEA and Change Controls
  • Ability to manage 5+ projects simultaneously

Nice-to-have

  • Masters degree in Chemistry, Biology, or Biotechnology
  • Six Sigma certification
  • Experience facilitating FMEAs
  • Systems or clinical engineering background
  • Strong cross-department collaboration skills

Key Requirements

  • Bachelor of Science Degree required
  • Minimum 4 years QA/QE experience in cGMP
  • Minimum 2 years risk management experience
  • Knowledge of FDA, ISO 13485, and ISO 14971
  • Six Sigma certification preferred

Work Rights

Not specified

Tailored Resume

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