Staff Engineer – Mms Projects & Capa

BD

San Diego, CA, USA
Base: $124,700.00 - $205,800.00 usd annual; bonus/...
Fully remote
Bachelor's degree in engineering or science
5 years engineering experience in medical device
Root cause investigation expertise
This role partners with cross-functional teams across R&D, Quality, Operations, and Regulatory to execute high-impact projects with a strong emphasis on CAPA excellence

Job Summary

  • This role partners with cross-functional teams across R&D, Quality, Operations, and Regulatory to execute high-impact projects with a strong emphasis on CAPA excellence.
  • The Staff Engineer is responsible for overseeing the BD R&D CAPA portfolio, ensuring issues are effectively investigated, resolved, and prevented from recurring.
  • BD offers a culture that values professional growth, encouraging associates to learn and become their best self while advancing the world of health.

Matching Summary

This role partners with cross-functional teams across R&D, Quality, Operations, and Regulatory to execute high-impact projects with a strong emphasis on CAPA excellence.

Salary

Base: $124,700.00 - $205,800.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive package including rewards and recognition programs

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering or Science
  • 5 years engineering experience in medical device
  • Root cause investigation expertise
  • FDA regulations and ISO 13485 compliance
  • Cross-functional project management

Nice-to-have

  • Lean and Six Sigma Green or Black Belt
  • Trackise CAPA documentation system experience
  • Change management experience
  • Audit participation experience
  • Strong analytical and critical thinking skills

Key Requirements

  • Bachelor's degree in Engineering or Science
  • Minimum 5 years of engineering experience
  • Experience within the medical device industry
  • Knowledge of FDA regulations (21 CFR 820)
  • Knowledge of ISO 13485 standards

Work Rights

Not specified

Tailored Resume

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