Senior Project Engineer - Automation

Medtronic Diabetes

Base: $120,000 to $150,000 py; bonus/equity: incen...
Not specified (assumed to be hybrid based on industry norms).
Ms project and project online proficiency
Fda qsr and eu mdr regulatory knowledge
Iq oq pq validation experience
Medtronic Diabetes is seeking a Senior Project Engineer specializing in automation to lead and coordinate projects for new product development and lifecycle management. The ideal candidate will possess advanced engineering qualifications and extensive experience in regulatory compliance and project management within the medical device industry

Job Summary

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

Matching Summary

Match Score: 85

Medtronic Diabetes is seeking a Senior Project Engineer specializing in automation to lead and coordinate projects for new product development and lifecycle management. The ideal candidate will possess advanced engineering qualifications and extensive experience in regulatory compliance and project management within the medical device industry.

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 validation experience
  • DFMEA PFMEA and DFMA expertise
  • Lean Six Sigma continuous improvement
  • GMP GDP documentation practices
  • 510(k) submission preparation

Nice-to-have

  • AGILE QMS system familiarity
  • ERP and BOM management skills
  • Design of Experiments (DOE) application
  • Cross-functional team leadership
  • Resource planning via PDWare

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 specific tools and regulations listed
  • Automation engineering background required

Work Rights

Not specified

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