- Develop and establish manufacturing processes based on product specifications and DFM principles
- Run Design of Experiments (DOE) to improve yield and efficiency
- Conduct equipment qualification and process validation (IQ/OQ/PQ)
- Lead projects involving new production equipment, tooling, and process improvements
- Drive cost reduction initiatives and understand Cost of Goods Sold (COGS)
- Apply Lean Manufacturing and DMAIC tools to improve quality and throughput
- Coordinate design, procurement, build, and debugging of tooling and test equipment
- Partner cross-functionally with R&D, Quality, Finance, and Operations
- Ensure compliance with FDA regulations, QMS, EMS, and OSHA standards
- Mentor and coach technicians, operators, and trainers
- Support divisional and company-wide quality initiatives
- Bachelor's Degree in Chemical, Mechanical, Industrial Engineering or related field
- 5+ years of Manufacturing Engineering experience in medical device or regulated industry
- Hands-on experience with DOE, process validation, and equipment qualification
- Strong knowledge of FDA regulations, QMS, and Design Controls
- Experience in matrixed, cross-functional environments
- Strong analytical, problem-solving, and project management skills
- Proficient in MS Office Suite
- Medical device manufacturing experience
- Experience partnering closely with R&D
- Delivery system/process yield improvement experience
- Lean Six Sigma Green or Black Belt certification
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Job Title: Manufacturing Engineer · Location: 177 East County Rd B – Woodridge, St. Paul, MN 55117 · Duration: 6 Months · Work Arrangement: 100% Onsite · Pay Range: $35–$38 per hour (W2) · We are seeking a "Manufacturing Engineer" to join one of our leading healthcare clients. · ...
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Manufacturing Engineer - St Paul - Intellectt Inc
Description
Hiring for Manufacturing Engineer - Medical Device / Regulated Manufacturing in St Paul, Minnesota,
Industry: Medical Device / Regulated Manufacturing
Position Summary
We are seeking a results-driven Manufacturing Engineer to support process development, yield improvement, equipment qualification, and new product introductions within a regulated medical device environment. The ideal candidate will have strong DOE experience, Lean manufacturing expertise, and FDA-compliant manufacturing knowledge.
Key Responsibilities
Required Qualifications
Preferred Qualifications
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