Manufacturing Engineering

Job Title: Manufacturing Engineer

Location: Minnetonka, MN

Duration: 12 Months

Job Summary: 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.
Key Responsibilities:
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.
Basic Qualifications:
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.
Preferred Qualifications:
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.