Stavan Shah

About Stavan Shah

Passionate mechanical engineer with 7.5 years of experience working in Pharmaceutical, Biopharmaceutical, Automated machinery and Manufacturing industries. Worked in New Product Development and New Product Introduction to bring forth design, development, and innovation. Competent in using Creo, Catia, Siemens NX, SolidWorks, ANSYS and AutoCAD software for engineering drawings, models and FEA analysis. Adept at collaborating cross functionally with various departments to deliver projects on time and within budget.I have a great passion for bringing products to life and improving people\'s quality of life. I thrive in a collaborative environment as I enjoy learning and sharing with different people, but I also manage to produce work efficiently by myself. My specialties in mechanical design, prototyping, data analysis, CAD modeling, fabrication, project management and design for manufacturing have allowed me to quickly take a concept and transform it into effective product.My core competencies include- 3D CAD Modeling using Catia, Creo, Siemens NX and Solidworks- 2D layouts using AutoCAD- FEA analysis for stress/strain, structural, thermal and optimization analysis using Creo, Catia and ANSYS- Quality Management System for tracking and documenting Notice of Events, Corrective & Preventive Action, Change Control - Data Analysis of thermal data for controlled temperature units- Fabrication and manufacturing of equipment- Assembly and testing of machines- Executing qualification protocols like IQ/OQ/PQ- Managing several projects and delivering results- Communicating with different departments to get work done

Experience

1. Senior Mechanical Process Engineer

   BD

   Aug 2025 — Present · Sumter, SC, US

   Spearheading the production ramp-up of a $45M integrated manufacturing suite. Coordinated the commissioning of automated subsystems including high-speed assembly, conveyor transport, and end-of-line packaging to ensure seamless flow and GMP compliance in a cleanroom setting.• Initiated process improvement efforts on the high-speed automated line by collecting data from HMI/PLC and manually with a focus on cycle time reduction, reliability improvements, and workflow optimization.• Executed 3 IQ protocols and authored the PQ protocol, collaborating cross-functionally to support FAT/SAT/OQ/PQ validation and ensured full safety regulatory and technical compliance.• Investigated and resolved machine performance issues using 5 Why, Fishbone, and DMAIC methodologies; drafted and approved deviations in 1 week by collaborating cross functionally with various departments.• Developed 11 Test Method Validation (TMV) protocols in 2 weeks, designing attribute and variable sampling plans and coordinating PLC mode configurations required for TMV execution.• Identified and escalated a vision system failure before SAT by utilizing the HMI to run machine diagnostics in challenge mode, ensuring critical defect detection.• Debugged machines while operating by identifying the alarm/warning/fault and looking for cause like stuck components or components jammed to keep it running.• Performed statistical analysis for vision system data in Minitab, including Ppk studies with maximum 30% acceptance thresholds, and used findings to drive data based decision making and process adjustments.

Education

• Western Michigan University

  Master of Science - MS, Mechanical Engineering

• K J Somaiya Polytechnic

  Diploma, Mechanical Engineering

  2010 — 2013

• University of Mumbai

  Bachelor of Engineering, Mechanical Engineering