Senior Project Engineer - Automation

MEDTRONIC

North Haven, CT, US
Base: $120,000 to $150,000 py; bonus: $1,000 emplo...
Not specified (assumed to be hybrid based on industry standards).
Ms project and project online proficiency
Fda qsr and eu mdr regulatory knowledge
Iq oq pq gage r&r tmv doe ppap experience
Medtronic is seeking a Senior Project Engineer in Automation to coordinate new product development and manage ongoing projects, ensuring compliance with FDA regulations and quality standards. The ideal candidate will have a strong engineering background and experience in project management, particularly within the medical device sector

Job Summary

  • This role leverages cross-functional groups to evaluate, develop, and coordinate projects for new product development and ongoing lifecycle management of products and therapies.
  • The position requires navigating FDA QSR, EU MDR, ISO 13485, and ISO 14971 regulations while conducting formal process validations and design failure mode analyses.
  • Employees are eligible for a $1,000 referral bonus, incentive plans, 401(k) matching, and comprehensive benefits including paid time off and stock purchase plans.

Matching Summary

Match Score: 85

Medtronic is seeking a Senior Project Engineer in Automation to coordinate new product development and manage ongoing projects, ensuring compliance with FDA regulations and quality standards. The ideal candidate will have a strong engineering background and experience in project management, particularly within the medical device sector.

Salary

Base: $120,000 to $150,000 per year; Bonus: $1,000 employee referral program available; Benefits: Incentive plans, 401(k) match, short-term disability, PTO, holidays, ESPP

Skills & Requirements

Must-have

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

Nice-to-have

  • Agile QMS system coordination
  • ERP and BOM creation support
  • Cross-functional team leadership
  • Resource tracking integration skills

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 MS Project and Project Online
  • Minimum 2 years experience with FDA QSR and EU MDR regulations
  • Minimum 2 years experience with IQ OQ PQ and PPAPs
  • Minimum 2 years experience with DFMA DFMEA and PFMEA
  • Minimum 2 years experience with Lean Six Sigma methodologies
  • Minimum 2 years experience with GMP and GDP practices
  • Minimum 2 years experience with FDA 510(k) submissions
  • Minimum 2 years experience with AGILE QMS and ERP systems

Work Rights

Not specified

Tailored Resume

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