Job Title: Development Process Engineer
Location: St. Paul, MN
Duration: 12 Months
Job Summary:
Seeking an experienced Development Process Engineer with 5+ years of experience in the medical device or regulated manufacturing industry to drive process development, equipment validation, yield improvement, and new product introductions. The ideal candidate will lead cross-functional manufacturing initiatives, apply Lean Six Sigma methodologies, ensure FDA/QMS compliance, and support continuous improvement efforts while collaborating with R&D, Quality, Operations, and Finance.
Key Responsibilities
- Design and execute Design of Experiments (DOE) to optimize manufacturing processes, improve yield, and increase efficiency.
- Lead process development, equipment qualifications (IQ/OQ/PQ), and process validations.
- Manage projects involving new production equipment, tooling, automation, and cost reduction initiatives.
- Drive continuous improvement using Lean Manufacturing, Six Sigma, DMAIC, and root cause analysis tools.
- Coordinate the design, procurement, installation, and debugging of tooling, machinery, and test equipment.
- Collaborate cross-functionally with R&D, Quality, Operations, and Finance to define and optimize manufacturing processes.
- Mentor and provide technical guidance to technicians, operators, and manufacturing personnel.
- Ensure compliance with FDA regulations, Design Controls, QMS, EMS, Process Validation, and Quality Control requirements.
- Evaluate manufacturing processes using Design for Manufacturability (DFM) principles and Cost of Goods Sold (COGS) considerations.
- Support new product introductions while improving product quality, throughput, and manufacturing capacity.
Skills Required
- Manufacturing Engineering
- Process Development & Process Improvement
- Design of Experiments (DOE)
- Process Validation (IQ/OQ/PQ)
- Equipment Qualification
- Lean Manufacturing
- Six Sigma / DMAIC
- Root Cause Analysis
- Design for Manufacturability (DFM)
- New Product Introduction (NPI)
- Tooling & Equipment Development
- Automation & Manufacturing Equipment
- Yield Improvement
- Cost Reduction
- Capacity Improvement
- Quality Control
- Design Controls
- FDA Regulations
- Quality Management Systems (QMS)
- Environmental Management Systems (EMS)
- COGS Analysis
Preferred Qualifications
- Medical Device Manufacturing Experience
- Collaboration with R&D Teams
- Delivery System Manufacturing Experience
- Lean Six Sigma Green Belt or Black Belt Certification
- Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint)
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