POSTED 02/27/2025
Manufacturing Engineer
Location: Minneapolis, MN
Manufacturing Engineer
Minneapolis, MN
Currently looking for skilled individuals to fill the direct hire position of Manufacturing Engineer opening with a company located in Minneapolis, MN. Interested candidates should have 3-5 years of experience in injection molding, 3D printing, or other regulated industries.
Manufacturing Engineer Job Description:
- Develop and integrate pre- and post‐molding operations including labeling, packaging, fixturing, ultrasonic and spin welding, gluing, leak testing, and washing process definitions.
- Define process parameters for new production processes and optimize them for efficiency and quality.
- Collaborate with tooling, processing, and quality teams to ensure smooth production ramp‐up for new molding and additive manufacturing projects.
- Support factory layout planning and capacity optimization efforts for new manufacturing processes.
- Identify opportunities for automation and process improvements to increase manufacturing efficiency.
- Train manufacturing leads on new/updated manufacturing procedures.
- Initiate and manage engineering change orders (ECOs) to ensure smooth implementation of process changes.
- Set up and manage bills of materials (BOMs) for new products and ensure alignment with production requirements.
- Work within ERP and QMS systems to track and manage process changes, material requirements, and production workflows.
- Develop and author IQ/OQ/PQ validation protocols for new pre- and post‐molding processes and secondary manufacturing operations.
- Support Quality Assurance in conducting First Article Inspections (FAI) and documentation review.
- Define critical process parameters (CPPs) and critical quality attributes (CQAs) to ensure process reliability.
- Help define control dimensions during molding, using statistical analysis to validate that if a single critical dimension is within tolerance, other dependent dimensions will also be within tolerance.
- Active participant in CAPA and Customer Complaint meetings.
Manufacturing Engineer Job Requirement:
- Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related field preferred.
- Preferred experience in injection molding, 3D printing, or other regulated industries such as military, aerospace, medical device, or food manufacturing.
- Experience with process validation, IQ/OQ/PQ, and quality documentation.
- Strong manufacturing process development and quality validation expertise.
- Proficiency in process validation (IQ/OQ/PQ), documentation, and quality systems.
- Knowledge of CAD platforms and design experience for fixturing and jigs, SolidWorks preferred.
- Experience in pre- and post‐molding operations such as initiating ECOs, setting up BOMs, labeling, packaging, fixturing, ultrasonic and spin welding, gluing, leak testing, and washing.
- Strong personal time management skills to effectively align individual timelines with broader project schedules.
- Strong analytical and problem‐solving skills with a hands‐on approach to troubleshooting process issues.
- Experience working within ERP and QMS systems; IQMS experience is a significant benefit.
- Proficiency in label‐generating software, Minitab, and inspection tools such as CMM, Zeiss, and Vertex vision systems.
- Knowledge of lean manufacturing, Six Sigma, and process improvement methodologies.
- Familiarity with FDA, ISO 13485/9001, and other regulated industry manufacturing standards is a plus.
- Strong communication skills, both written and verbal, with the ability to document and present findings effectively.
Compensation for Manufacturing Engineer:
The starting salary for the Manufacturing Engineer position is $85-$95k annually plus benefits (401k plan, health and life insurance, and PTO).