Sr. R&d Engineer

Medtronic UK

Irvine, United States
Base: $124,000 to $156,000 py; bonus/equity: incen...
Hybrid
Class ii and class iii medical devices
Fda qsr, iso13485, iso14971
Product labeling design and development
Provide R&D and quality engineering support for Medtronic Neurovascular devices, including design transfers, scale-up, and operational support

Job Summary

  • Provide R&D and quality engineering support for Medtronic Neurovascular devices, including design transfers, scale-up, and operational support.
  • Navigate complex regulations such as FDA QSR, ISO13485, and EU Medical Device Directive, while managing product labeling and supplier activities.
  • The company offers a comprehensive benefits package including health, dental, vision insurance, retirement plans, and tuition assistance.

Matching Summary

Provide R&D and quality engineering support for Medtronic Neurovascular devices, including design transfers, scale-up, and operational support.

Salary

Base: $124,000 to $156,000 per year; Bonus/Equity: Incentive plans; Benefits: Health, Dental, Vision, 401(k), PTO

Skills & Requirements

Must-have

  • Class II and Class III medical devices
  • FDA QSR, ISO13485, ISO14971
  • Product labeling design and development
  • Supplier activities and CAPA
  • Risk analysis and health hazard assessment
  • Post-market surveillance and complaint investigation

Nice-to-have

  • Global well-being program
  • Employee Stock Purchase Plan
  • Incentive plans and 401(k) match

Key Requirements

  • Master's degree in Technology Management or Engineering
  • 2 years of R&D or manufacturing engineering experience
  • 2 years experience with Class II/III medical devices
  • 2 years experience with medical device regulations
  • 2 years experience with product labeling and supplier activities
  • 2 years experience with risk analysis and CAPA
  • 2 years experience with post-market surveillance
  • 2 years experience with Measurement System Analysis
  • 2 years experience with Product Life Cycle Management, GMP, GDP

Work Rights

Not specified

Tailored Resume

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