Engineer, Senior - Npi*

Integer

Unknown
New product introduction (npi) quality support
Test method development and validation
Root cause analysis and corrective actions
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs and specialized battery markets, guided by six core values including Customer, Innovation, and Integrity

Job Summary

  • Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs and specialized battery markets, guided by six core values including Customer, Innovation, and Integrity.
  • The role involves applying diversified engineering knowledge to ensure NPI projects meet quality standards, leading test method development, supporting regulatory inspections, and driving continuous improvement initiatives.
  • The position requires leadership in quality assurance activities, coaching team members, managing complaint investigations, and supporting manufacturing excellence and market-focused innovation strategies.

Matching Summary

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs and specialized battery markets, guided by six core values including Customer, Innovation, and Integrity.

Skills & Requirements

Must-have

  • New Product Introduction (NPI) quality support
  • Test method development and validation
  • Root cause analysis and corrective actions
  • Statistical analysis using Minitab
  • Quality Management System (QMS) adherence
  • Cross functional team leadership
  • Process and product validation

Nice-to-have

  • Coaching and mentoring engineers
  • Continuous improvement leadership
  • Collaboration and communication skills
  • Calm demeanor in high energy environments
  • Positive, can-do attitude
  • Experience with ISO14971 risk management
  • Knowledge of workplace organization (5S)

Key Requirements

  • Bachelor’s degree in engineering or related field
  • 7+ years progressive engineering experience or 15+ years relevant experience without degree
  • 6-Sigma Green Belt minimum, Black Belt preferred
  • Strong knowledge of FDA and international regulations
  • Subject matter expert in statistics and Minitab
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter