Industrial Engineer

1 week ago

Pleasanton, California, United States Intellectt Inc Full time $90,000 - $120,000 per year

Job Title:
Industrial Engineer

Location:
Pleasanton, CA

Duration:
12 Months

Position Summary:

We are seeking a skilled Industrial Engineer with a background in the medical device industry to join our manufacturing and operations team in Pleasanton, CA. The ideal candidate will be responsible for driving process improvements, optimizing production workflows, and supporting continuous improvement initiatives to enhance efficiency, quality, and compliance within a regulated environment.

Key Responsibilities:

  • Analyze, design, and optimize manufacturing processes to improve throughput, reduce waste, and ensure consistent product quality.
  • Develop and maintain process documentation, including standard operating procedures (SOPs), work instructions, and process flow diagrams.
  • Conduct time studies, capacity analyses, and layout design for manufacturing lines to improve productivity.
  • Collaborate with cross-functional teams (Manufacturing, Quality, Engineering, Supply Chain) to support new product introductions (NPI) and process validation activities.
  • Implement Lean Manufacturing and Six Sigma methodologies to enhance operational performance.
  • Support root cause analysis and corrective/preventive actions (CAPA) for process-related issues.
  • Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards in all engineering and manufacturing practices.
  • Participate in equipment qualification, process validation (IQ/OQ/PQ), and continuous improvement projects.
  • Provide technical support to manufacturing teams and assist in troubleshooting production issues.

Qualifications & Experience:

  • Bachelor's degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or a related discipline.
  • 4+ years of experience in an Industrial Engineering role within the medical device or regulated manufacturing industry.
  • Strong understanding of GMP, ISO 13485, FDA regulations, and validation processes.
  • Hands-on experience with process optimization tools such as Lean, Six Sigma, or Kaizen.
  • Proficiency in CAD tools and manufacturing layout design is preferred.
  • Excellent analytical, problem-solving, and communication skills.
  • Ability to work collaboratively in a cross-functional, fast-paced environment.

Preferred Skills:

  • Green Belt or Lean Certification preferred.
  • Experience with ERP/MES systems and data analysis tools (Excel, Minitab, Power BI, etc.).
  • Knowledge of automation or robotics applications in manufacturing is a plus.

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