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Development Process Engineer

Intellectt INC

Saint Paul, MN

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JOB DETAILS
SKILLS
Analysis Skills, Automation, Career Development, Continuous Improvement, Cost Control, Cost of Goods Sold (COGS), Cross-Functional, Debugging Tools, Environmental Management Systems, Equipment Validation, Experiment Design, FDA (Food and Drug Administration), FDA Requirements, Finance, Lean Manufacturing, Lean Six Sigma, Machine Tool, Maintain Compliance, Manufacturing, Manufacturing Automation, Manufacturing Design, Manufacturing Engineering, Manufacturing Equipment, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Equipment, Mentoring, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Process Development, Process Engineering, Process Improvement, Process Validation, Product Support, Product/Service Launch, Productivity Management, Project/Program Management, Purchasing/Procurement, Quality Control, Quality Management, Regulatory Compliance, Research & Development (R&D), Root Cause Analysis, Six Sigma Black Belt, Six Sigma DMAIC, Six Sigma Green Belt, Technical Leadership, Test Equipment, United States Department of Energy (DOE)
LOCATION
Saint Paul, MN
POSTED
2 days ago

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)

About the Company

I

Intellectt INC

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