Sr Manager, Design Quality Process Improvement (hybrid)

Insulet

Multiple Locations
Base: $154,100.00 - $231,200.00; bonus/equity: may...
Hybrid
Continuous improvement initiatives
Medical device design controls
Regulatory compliance with fda and iso standards
The Sr Manager, Design Quality Process Improvement, is responsible for leading strategic and results-driven Continuous Improvement initiatives that enhance efficiency, compliance, and innovation across medical device design and development processes

Job Summary

  • The Sr Manager, Design Quality Process Improvement, is responsible for leading strategic and results-driven Continuous Improvement initiatives that enhance efficiency, compliance, and innovation across medical device design and development processes.
  • This position offers a comprehensive benefits package including medical, dental, and vision insurance, 401(k) with company match, paid time off, and additional employee wellness programs.
  • Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.

Matching Summary

The Sr Manager, Design Quality Process Improvement, is responsible for leading strategic and results-driven Continuous Improvement initiatives that enhance efficiency, compliance, and innovation across medical device design and development processes.

Salary

Base: $154,100.00 - $231,200.00; Bonus/Equity: May be eligible for incentive compensation; Benefits: Medical, dental, vision, 401(k) match, PTO, wellness programs

Skills & Requirements

Must-have

  • Continuous improvement initiatives
  • Medical device design controls
  • Regulatory compliance with FDA and ISO standards
  • Cross-functional collaboration
  • Software Development Life Cycle (SDLC) best practices
  • Process optimization and quality systems
  • Change management and training

Nice-to-have

  • Lean Six Sigma certification
  • Digital transformation leadership
  • Conflict resolution skills
  • Proactive quality culture
  • Stakeholder management
  • Program management skills

Key Requirements

  • Bachelor’s degree in engineering or Life Sciences
  • 8+ years medical device industry experience
  • Strong knowledge of design controls and quality systems
  • Experience with FDA QSR, ISO 13485, ISO 14971, IEC 62304
  • Experience implementing SDLC in regulated environments
  • Lean Six Sigma Green Belt or higher preferred

Work Rights

Not specified

Tailored Resume

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