Manager, Engineering

Integer

Base: $130,350-$173,800; bonus/equity: cash-based ...
Bachelor of science in engineering
Iso and regulatory standards knowledge
Fda regulations compliance experience
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 Leadership experience to continuously improve cycle times and reduce waste in all manufacturing processes.
  • The position offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and 80 hours of designated holidays.

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
  • ISO and regulatory standards knowledge
  • FDA regulations compliance experience
  • Process and Test Method Validations IQ OQ PQ PPQ
  • Lean manufacturing techniques application

Nice-to-have

  • Six Sigma Black Belt certification preferred
  • Mentoring junior staff capabilities
  • Cross-functional team leadership skills
  • Strong oral and written communication
  • Data driven analysis and decision making

Key Requirements

  • 10+ years of experience required
  • 5+ years in medical device industry
  • Master or PhD degree preferred
  • Six Sigma Black Belt certification preferred

Work Rights

Not specified

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