Principal Manufacturing Engineer – Medical Devices & Lean

Laborie; Maple Grove (MN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Volunteer time off

Medical insurance

HSA contributions

401k with match

Parental leave

Job summary

Laborie is seeking a Principal Manufacturing Engineer to shape manufacturing strategy across sites. You will lead high-impact projects, optimize processes, and mentor engineering teams while ensuring design transfer and production readiness for new products and updates.

You will drive validation activities and maintain compliance with ISO standards, delivering data-driven insights through planning and performance trend analysis.

Qualifications

• 12+ years' experience as Manufacturing/Production Engineer, or 8+ with Master's.
• Experience in medical device industry and DFM principles.
• Proficient with ERP SAP, SolidWorks, and MS Office.
• Lean manufacturing and continuous improvement experience.
• Knowledge of ISO 13485/ISO 9000 and health & safety regulations.
• Willingness to travel 25%.

Responsibilities

• Act as corporate SME, providing technical leadership and advising on strategy.
• Lead cross-functional projects with executive alignment to growth plans.
• Improve efficiency through Lean initiatives, line layouts, and time studies.
• Own design transfer and production readiness; mentor technicians and engineers.
• Lead IQ, OQ, PQ, MSA validation activities per ISO standards.
• Define testing methods and standards to ensure regulatory compliance and quality.

Skills

SAP ERP

SolidWorks

Microsoft Office

Lean Manufacturing

Data analysis

Project leadership

Education

Bachelor's in Mechanical, Electrical, or Manufacturing Engineering

Master's degree preferred

Job description

Laborie is seeking a Principal Manufacturing Engineer to shape manufacturing strategy across sites. You will lead high-impact projects, optimize processes, and mentor engineering teams while ensuring design transfer and production readiness for new products and updates.

You will drive validation activities and maintain compliance with ISO standards, delivering data-driven insights through planning and performance trend analysis.