Manufacturing Engineer

Job Title: Manufacturing Engineer
Location: Minnetonka, MN
Duration: 12 Months

We are seeking a Manufacturing Engineer to support manufacturing process improvements, quality initiatives, cost reduction, and operational efficiency while ensuring compliance with cGMP, quality, and safety standards.

• Identify root causes of manufacturing failures using structured problem-solving methodologies.
• Troubleshoot equipment by evaluating machine logic, electromechanical systems, and process controls.
• Support Design of Experiments, process validation, testing, and data analysis for continuous improvement.
• Evaluate equipment and manufacturing processes for suitability and develop improvement plans.
• Create and revise manufacturing documents, specifications, SOPs, safety instructions, validation protocols, risk assessments, and other technical documentation.
• Collaborate with engineers and technicians to develop improvements in materials, equipment, and manufacturing processes.
• Participate in cross-functional teams focused on continuous improvement, safety, quality, and regulatory compliance.
• Provide training to technicians and operators on SOPs and manufacturing procedures.

• Bachelor's degree in Engineering or an equivalent combination of education and experience.
• Previous engineering experience in a manufacturing environment.
• Familiarity with CAD, manufacturing, inventory, database, development, and project management software.
• Proficiency with Microsoft Excel and Microsoft Word.
• Familiarity with material testing and measurement methods.

• Experience working in GMP, FDA, ISO, or USDA-regulated manufacturing environments.
• Experience with statistical analysis software such as Minitab.
• Knowledge of cGMP and ISO 13485 requirements and practices.
• Experience with process improvement, troubleshooting, validation, and manufacturing documentation.