Role: Manufacturing Engineer

Location: Minnetonka, MN

Duration: 12 Months

Job Description:

As a Manufacturing Engineer, you will play a critical role in ensuring the efficient production of high-quality medical devices. This position requires a detail-oriented professional with strong technical expertise and a passion for continuous improvement.

Key Responsibilities:

• Develop, validate, and optimize manufacturing processes for medical devices in compliance with regulatory standards (e.g., FDA, ISO 13485).
• Collaborate with cross-functional teams, including R&D, Quality, and Supply Chain, to ensure seamless product transfers and launches.
• Design and implement tools, fixtures, and equipment to enhance manufacturing efficiency and reduce downtime.
• Conduct root cause analysis and implement corrective/preventive actions to address manufacturing issues.
• Drive process improvements through Lean Manufacturing, Six Sigma methodologies, and other best practices.
• Prepare and maintain manufacturing documentation, including process flow diagrams, work instructions, and standard operating procedures (SOPs).
• Support validation activities, such as IQ, OQ, PQ, and statistical process control (SPC).
• Monitor and analyze key performance indicators (KPIs) to ensure production goals are met or exceeded.
• Provide training to production staff on new processes, tools, and equipment.
• Ensure compliance with all safety and quality regulations.

Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Industrial, or related field preferred).
• 3+ years of experience in a manufacturing environment, preferably within the medical device industry.
• Familiarity with FDA regulations, ISO 13485 standards, and Good Manufacturing Practices (GMP).
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and experience with ERP/MES systems.
• Strong problem-solving and analytical skills with a hands-on approach to troubleshooting.
• Excellent communication and collaboration skills to work effectively in a team-oriented environment.
• Certification in Lean Six Sigma (preferred).