Medical Device Manufacturing Engineer: Lean Process Expert

Laborie; Minneapolis (MN); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, vision

401k with company match

Parental leave

Wellness programs

Job summary

Laborie seeks a Manufacturing Engineer to support and enhance production operations by improving quality, reducing defects, and resolving non-conforming material issues within an ISO 9001 and ISO 13485 environment. The role focuses on development, qualification, and launch of new products and updates to existing medical devices, ensuring compliant design transfer into manufacturing.

Working closely with cross-functional teams, the engineer applies lean principles and strong problem-solving

Qualifications

• Bachelor's degree in Biomedical, Mechanical, or Industrial Engineering or related field; 2+ years of Manufacturing Process Engineer experience.
• Lean manufacturing methods and ISO 13485/ISO 9001 experience.
• Medical device environment, GMP practices, and cross-functional collaboration.
• DFM knowledge, Six Sigma Lean practices, and ERP experience.
• Structured problem-solving (5-Why, Fishbone, DMAIC) and strong communication.
• Willingness to travel up to 5% domestically or internationally.

Responsibilities

• Design and optimize manufacturing processes and layouts for drug-device products.
• Advance coating, packaging, process capabilities, and implement improvements.
• Engage in PFMEA, DFMEA, Process Mapping, and CTQ reviews; support DFM activities.
• Manage line validation activities (IQ/OQ/MSA/PQ) and related documentation.
• Lead Lean initiatives to reduce waste and improve efficiency; analyze costs and schedules.
• Create process flow charts, tooling strategies, capacity analyses, and EHS plans.
• Prepare testing protocols, work instructions, control plans, and product/process reports.

Skills

Lean manufacturing

Six Sigma Green Belt

Lean Six Sigma

Project management

Problem-solving

Communication

Travel readiness

Education

Bachelor's degree in Biomedical, Mechanical, or Industrial Engineering or related field

Tools

ERP systems

Job description

Laborie seeks a Manufacturing Engineer to support and enhance production operations by improving quality, reducing defects, and resolving non-conforming material issues within an ISO 9001 and ISO 13485 environment. The role focuses on development, qualification, and launch of new products and updates to existing medical devices, ensuring compliant design transfer into manufacturing.

Working closely with cross-functional teams, the engineer applies lean principles and strong problem-solving