Advanced Manufacturing Engineer

Position Overview

We are seeking an Advanced Manufacturing Engineer based in Milwaukee, WI 53219 on a 12‐month contract. This role offers Compensation: Pay Rate: $40.54/Hr on W2 and is focused on completing risk retirement testing, equipment qualification, and process validation for both new product development and existing manufacturing. You will work closely with Engineering, Advanced Manufacturing Engineering, and Manufacturing teams to implement process updates and ensure strict adherence to FDA regulated Medical Device Manufacturing standards.

Key Responsibilities

• Drive improved product quality by identifying manufacturing issues, developing cost-effective solutions, and overseeing their implementation into production.
• Collaborate with engineering and manufacturing leadership to resolve quality and manufacturing challenges related to processes, tooling, equipment, and product design.
• Monitor and enhance productivity using Lean Six Sigma or related tools while ensuring customer commitments are met on time and within budget.
• Focus on manufacturability in new product programs by driving rigorous process capability assessments, process layout optimizations, tooling and equipment developments, and QMS Design Transfer execution.
• Ensure regulatory compliance through Qualification & Validation by determining processes requiring validation, developing comprehensive plans, executing tests, and performing final analyses.
• Collaborate with cross-functional teams, including Operations and Quality Assurance, to continuously simplify and improve Quality Management System methods while coordinating with facilities and maintenance for capacity planning.
• Comply with the GEHC Quality Manual, Quality Management System policies, and applicable laws; complete all required Quality & Compliance training; and promptly address any quality or compliance concerns.
• Apply best practices in document control, design transfer, verification, validation, and related regulatory requirements.

Required Qualifications

• B.S. Degree in Mechanical, Electrical, Industrial Engineering or a related technical field with 3 years’ experience; or Associates Degree with 5 years’ experience; or High School Diploma with 7 years’ related experience in production, engineering, or troubleshooting.
• Previous experience in owning or qualifying manufacturing equipment and processes.
• Proven troubleshooting, analytical, and planning skills with the ability to work independently.
• Excellent communication skills (written and verbal) across all levels of the organization.
• Ability to identify and implement Best Practices.

Preferred Qualifications

• MS/PhD in a technical field.
• 7+ years of industrial experience in Manufacturing Engineering.
• 6-sigma DMAIC & DFSS certification.
• Experience in process-intensive manufacturing and product/process development.
• Solid working knowledge of GEHC QMS procedures for GMP.
• Experience in developing tools and templates.
• Demonstrated program or project management skills and experience in owning production processes to improve yield and quality.
• Experience working with global teams.