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 DMAIC Six Sigma approaches to solve issues and reduce variation in manufacturing processes.
  • 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 Validations IQ OQ PQ PPQ

Nice-to-have

  • Six Sigma Black Belt certification
  • Master or PhD degree preferred
  • Lean Leadership experience
  • Strong mentoring and coaching skills
  • Cross-functional team collaboration

Key Requirements

  • Minimum 10 years of total experience
  • Minimum 5 years in medical device industry
  • Bachelor of Science in Engineering required
  • Knowledge of ISO and regulatory standards mandatory
  • Six Sigma Black Belt certification preferred

Work Rights

Not specified

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