Senior Engineering Manager - Lean Six Sigma & Regulatory

Integer Holdings Corporation; Brooklyn Park (MN); On-site; USD 130,000 - 191,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life insurance

Adoption benefits

401(k) with company match

Paid time off

Job summary

Integer Holdings Corporation is seeking a senior engineering leader to drive Quality and Regulatory initiatives across facilities. You will champion Lean and Six Sigma approaches, lead major product ramps, and coordinate cross-functional teams including finance, HR, operations and sales.

The role emphasizes mentoring, process optimization, and adherence to FDA and ISO standards. A BS in engineering with 10+ years of experience (5+ in medical devices) is required.

Qualifications

• BS in Engineering/Technical field required; 10+ years total experience (5+ in medical devices).
• Six Sigma Black Belt and ISO regulatory knowledge preferred.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Adheres to Integer's safety, environmental, quality and regulatory requirements.
• Identify, track, resolve and communicate major new product ramps and cost initiatives.
• Lead development and implementation of Quality, Regulatory policies and procedures.
• Plan resources to execute IQ/OQ/PQ/PPQ per procedures and guidelines.
• Communicate procedures, improvements and technical info clearly inside and outside the company.
• Prepare or review documentation (specs, procedures, ECOs, reports) with accuracy.
• Apply Lean leadership to improve cycle times and reduce waste in processes.
• Lead DMAIC projects to reduce variation across processes.
• Plan, execute and manage cross-functional projects (new products, transfers, continuous improvement).
• Mentor staff, drive accountability, and develop team capabilities.
• Demonstrate engineering knowledge through practical application.
• Perform other duties as required.

Skills

Leadership

Multi-tasking

Lean manufacturing

Six Sigma Black Belt

Regulatory knowledge (ISO)

Education

Bachelor of Science in Engineering/Technical field

Master or PhD preferred

Job description

Integer Holdings Corporation is seeking a senior engineering leader to drive Quality and Regulatory initiatives across facilities. You will champion Lean and Six Sigma approaches, lead major product ramps, and coordinate cross-functional teams including finance, HR, operations and sales.

The role emphasizes mentoring, process optimization, and adherence to FDA and ISO standards. A BS in engineering with 10+ years of experience (5+ in medical devices) is required.