Sr. Manufacturing Engineer

Job Title: Sr. Manufacturing Engineer

Location: Minnetonka, MN

Duration: 12 Months

Job Summary:

We are seeking a Manufacturing Engineer with strong experience in medical device manufacturing, process development, validation, and continuous improvement. The ideal candidate will have hands-on experience developing and optimizing manufacturing processes while ensuring compliance with quality and regulatory requirements.

Qualifications and Requirements:

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related field
• 4 5+ years of experience in Manufacturing Engineering within the medical device industry
• Strong experience with Process Validation including IQ, OQ, and PQ
• Experience developing, characterizing, and optimizing manufacturing processes
• Experience developing and working with PFMEAs
• Experience with data analysis using Minitab
• Knowledge of Design for Manufacturability (DFM) principles
• Experience with Lean Manufacturing and Continuous Improvement
• Strong Root Cause Analysis and problem-solving skills
• Experience with tooling, fixtures, and equipment design
• Ability to troubleshoot production processes and provide equipment support
• Knowledge of FDA regulations, ISO 13485, GMP, and applicable quality systems
• Strong verbal and written communication skills
• Ability to work effectively both independently and as part of a team
• Strong organizational, multitasking, follow-up, and time-management skills
• Ability to work in a fast-paced and changing environment while meeting deadlines

Key Skills:

• Manufacturing Process Development and Optimization
• Process Validation IQ, OQ, PQ
• PFMEA and Risk Analysis
• Lean Manufacturing and Continuous Improvement
• Root Cause Analysis and Problem Solving
• Minitab and Data Analysis
• Design for Manufacturability
• Tooling, Fixture, and Equipment Design
• Production Troubleshooting
• FDA, ISO 13485, and GMP