Job Title: Manufacturing Engineer

Location: Minnetonka, MN - 55345

Key Responsibilities:

• Develop, implement, and maintain manufacturing processes for medical devices.
• Work closely with cross-functional teams, including R&D, Quality, and Operations, to improve production efficiency and resolve technical challenges.
• Conduct root cause analysis and provide technical solutions to resolve manufacturing problems.
• Participate in the design, development, and implementation of process improvements.
• Ensure adherence to industry standards and regulations (FDA, ISO, etc.).
• Collaborate on product design changes, including feasibility, cost analysis, and production capability.
• Support the transfer of new products from development to manufacturing.
• Assist with the validation and verification of manufacturing processes and equipment.
• Provide technical support for the production team and other departments.

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related field.
• 3+ years of experience in a manufacturing engineering role, preferably in the medical device industry.
• Experience with medical device manufacturing processes, regulations, and quality standards (FDA, ISO 13485).
• Strong problem-solving skills and experience with troubleshooting and process optimization.
• Knowledge of lean manufacturing principles and continuous improvement methodologies.
• Proficiency in CAD software (SolidWorks, AutoCAD, etc.) and MS Office Suite.
• Excellent communication skills and ability to work in a collaborative team environment.