Senior Project Engineer - Automation

Medtronic UK

Base: $120,000 to $150,000 py; bonus/equity: incen...
Ms project and project online proficiency
Fda qsr and eu mdr regulatory knowledge
Iq oq pq and gage r&r validation experience
The role involves leveraging cross-functional groups to evaluate and coordinate projects for new product development and ongoing lifecycle management of medical therapies

Job Summary

  • The role involves leveraging cross-functional groups to evaluate and coordinate projects for new product development and ongoing lifecycle management of medical therapies.
  • Candidates must ensure strict adherence to FDA QSR, EU MDR, ISO 13485, and ISO 14971 regulations while managing project plans via MS Project.
  • The position offers a competitive salary range of $120,000 to $150,000 per year along with comprehensive benefits including 401(k) matching and incentive plans.

Matching Summary

The role involves leveraging cross-functional groups to evaluate and coordinate projects for new product development and ongoing lifecycle management of medical therapies.

Salary

Base: $120,000 to $150,000 per year; Bonus/Equity: Incentive plans available; Benefits: 401(k) match, PTO, Stock Purchase Plan

Skills & Requirements

Must-have

  • MS Project and Project Online proficiency
  • FDA QSR and EU MDR regulatory knowledge
  • IQ OQ PQ and Gage R&R validation experience
  • DFMA DFMEA PFMEA analysis skills
  • Lean Six Sigma continuous improvement
  • GMP GDP documentation practices
  • FDA 510(k) submission management

Nice-to-have

  • Agile QMS system integration experience
  • ERP and BOM creation support
  • Cross-functional team leadership
  • Design of Experiments (DOE) application
  • Process validation coordination

Key Requirements

  • Master's degree in Engineering or related field with 2 years experience
  • Bachelor's degree in Engineering or related field with 5 years experience
  • Minimum 2 years experience with specified regulatory and validation tools
  • Relocation assistance not available for this position

Work Rights

Not specified

Tailored Resume

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