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