Senior Manufacturing Engineering Manager — Lean & Six Sigma

Integer Holdings; Plymouth (MN); On-site; USD 103,000 - 191,000; Full time

Job summary

Integer Holdings seeks a hands-on Manufacturing Engineer to support Operations and interact with customers, helping with quality systems and process engineering. The role requires leading product ramps, cost-reduction initiatives, and compliance with FDA and ISO standards.

Using Lean and Six Sigma, you will drive improvements in cycle times and waste reduction, while guiding IQ/OQ/PQ/PPQ validations and cross-functional team collaboration for successful outcomes.

Qualifications

• Bachelor's degree in Engineering/Technical field required.
• 10+ years of experience; 5+ in medical device industry.
• Six Sigma Black Belt certification preferred; knowledge of ISO and regulatory standards.

Responsibilities

• Adheres to Quality Management Systems, FDA regs, and safety requirements.
• Identify, track, and communicate major new product ramps and cost reduction initiatives.
• Lead the development and implementation of Quality and Regulatory requirements.
• Plan and execute IQ, OQ, PQ, PPQ validations per procedures.
• Communicate procedures and technical information clearly within and outside the company.
• Prepare and review accurate documentation (specifications, ECOs, reports).
• Promote Lean manufacturing to improve cycle times and reduce waste.
• Lead DMAIC projects to reduce variation and solve issues.
• Manage cross-functional project activities across finance, HR, operations, quality and sales.

Skills

Leadership

Multi-tasking

Six Sigma Black Belt

Regulatory standards

Education

Bachelor's in Engineering/Technical field

Master or PhD preferred

Job description

Integer Holdings seeks a hands-on Manufacturing Engineer to support Operations and interact with customers, helping with quality systems and process engineering. The role requires leading product ramps, cost-reduction initiatives, and compliance with FDA and ISO standards.

Using Lean and Six Sigma, you will drive improvements in cycle times and waste reduction, while guiding IQ/OQ/PQ/PPQ validations and cross-functional team collaboration for successful outcomes.