Atharv Patil

About Atharv Patil

Sr. Manufacturing & Quality Engineer with experience in medical device manufacturing, specializing in process improvement, NPI, and process validation (IQ/OQ/PQ). Experienced working on reducing nonconformances, improving first-pass yield, and strengthening inspection methods within ISO 13485 regulated environments. Experienced in NCR/CAPA management, root cause analysis (DMAIC, 8D), Lean manufacturing, and cross-functional collaboration to drive production efficiency and compliance. Skilled in fixture design, time studies, EPICOR routing optimization, and vision inspection systems (Keyence). Passionate about building robust, repeatable processes that improve quality, productivity, and overall operational performance.

Experience

1. Senior Manufacturing Engineer

   Avalign Technologies

   Apr 2024 — Present · Fort Wayne, IN, US

   Developed and revised work instructions and process documentation for finishing and assembly operations, improving process clarity and reducing recurring NCMRs.• Supported and executed process validations (IQ/OQ/PQ) for finishing and assembly processes, ensuring equipment qualification, repeatability, and compliance with medical device quality requirements.• Designed and implemented assembly fixtures to improve part alignment, reduce scrap, and enhance operator consistency.• Conducted time studies on critical components and updated routings in EPICOR to optimize cycle times and production flow.• Applied DMAIC methodology to investigate recurring defects by identifying critical quality parameters and implementing sustainable corrective actions.• Performed GEMBA walks and collaborated with production teams to improve workflow, ensure adherence to ISO 13485 standards, and drive continuous improvement.

Education

• The New college, Kolhapur

  Intermediate, Physics, Chemistry, Mathematics, Biology

• Lamar University

  Master's degree, Industrial and System Engineering

• University of Mumbai

  Bachelor of Engineering - BE, Mechanical Engineering