Industrial Engineer

Job Title: Industrial Engineer – Medical Devices

Location: Appleton, WI

Job Summary: The Industrial Engineer supports the design, optimization, and continuous improvement of manufacturing processes for medical device products in a regulated environment. The role focuses on improving efficiency, quality, cost, and compliance while ensuring processes meet applicable regulatory and quality system requirements.

Key Responsibilities:

• Analyze and optimize manufacturing processes to improve productivity, yield, and cost efficiency.
• Develop and maintain standard work, process flows, capacity models, and line balancing.
• Support New Product Introduction (NPI), process transfers, and scale-up activities
• Perform time studies, value stream mapping, and root cause analysis for process improvements.
• Collaborate cross-functionally with Manufacturing, Quality, R&D, and Supply Chain teams
• Ensure processes comply with medical device regulations and quality system requirements
• Support risk management activities (e.g., PFMEA, process risk assessments)
• Assist with process validation, continuous improvement initiatives, and change management

Regulatory & Standards Knowledge:

• FDA 21 CFR Part 820 (QSR)
• ISO 13485 (Quality Management Systems)
• ISO 14971 (Risk Management)
• GMP / GxP principles
• Lean Manufacturing and Continuous Improvement tools

Education & Qualification Requirements:

• Bachelor’s degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or related field.
• 2–5 years of experience in medical device or regulated manufacturing environment
• Experience with Lean, Six Sigma, or continuous improvement methodologies preferred
• Strong analytical, problem-solving, and documentation skills.