Senior Manufacturing Engineering Manager - Lean Six Sigma

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

Benefits offered by this job

Medical, dental, vision

Disability and life insurance

401(k) with company matching

Paid time off and holidays

Job summary

Integer Holdings Corporation is seeking a Manufacturing Engineering professional to provide hands-on support for Operations, quality systems engineering, and process engineering. The role emphasizes adherence to QMS, FDA regulations, ISO standards, and Lean initiatives to improve cycle times and reduce waste.

Qualifications include a BS in engineering or technical field, 10+ years in the medical device sector, and preferred Six Sigma Black Belt; Master/PhD is a plus.

Qualifications

• BS in engineering or technical field required
• 10+ years of experience, 5+ in medical device industry
• Master/PhD preferred

Responsibilities

• Adheres to FDA regulations, ISO standards, and QMS requirements
• Identify, track and communicate major new product ramps and cost reduction initiatives
• Lead quality and regulatory requirements including Integer policies and procedures
• Plan, develop and ensure resources for IQ, OQ, PQ, PPQ validations
• Mentor staff and lead cross-functional teams to achieve business results

Skills

Leadership

Six Sigma Black Belt

Regulatory knowledge

Quality management

Communication

Education

Bachelor of Science in Engineering/Technical field

Master's or PhD preferred

Job description

Integer Holdings Corporation is seeking a Manufacturing Engineering professional to provide hands-on support for Operations, quality systems engineering, and process engineering. The role emphasizes adherence to QMS, FDA regulations, ISO standards, and Lean initiatives to improve cycle times and reduce waste.

Qualifications include a BS in engineering or technical field, 10+ years in the medical device sector, and preferred Six Sigma Black Belt; Master/PhD is a plus.