Manager, Engineering

Integer

Base: $130,350-$173,800; bonus/equity: cash-based ...
Bachelor of science in engineering
10+ years engineering experience
5+ years medical device industry
The role requires leading the development and implementation of Quality and Regulatory requirements including FDA regulations and company policies

Job Summary

  • The role requires leading the development and implementation of Quality and Regulatory requirements including FDA regulations and company policies.
  • Candidates must apply Lean manufacturing techniques and Six Sigma DMAIC approaches to continuously improve cycle times and reduce waste.
  • The position offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and paid time off.

Matching Summary

The role requires leading the development and implementation of Quality and Regulatory requirements including FDA regulations and company policies.

Salary

Base: $130,350-$173,800; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, 401(k) match

Skills & Requirements

Must-have

  • Bachelor of Science in Engineering
  • 10+ years engineering experience
  • 5+ years medical device industry
  • ISO and regulatory standards knowledge
  • Process and Test Method Validation IQ OQ PQ PPQ
  • FDA regulations compliance

Nice-to-have

  • Six Sigma Black Belt certification preferred
  • Lean Leadership experience
  • Strong mentoring and coaching skills
  • Cross-functional team collaboration
  • Data driven analysis and decision making

Key Requirements

  • Minimum 10 years total experience
  • Minimum 5 years in medical device industry
  • Bachelor of Science degree required
  • Master or PhD preferred
  • Knowledge of ISO standards mandatory

Work Rights

Not specified

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