Summary
Overview
Work History
Education
Skills
Training And Workshops
Declaration
Projects And Presentations
Additional Information
Timeline

NILESH P

Summary

Forward-thinking Process Engineer with more than Seven years of experience in process design and establishing manufacturing routines. Known for great time management, effective multitasking and detail-oriented planning. Dedicated to expanding throughput and reducing unnecessary project waste. Eager to wring every drop of performance from available budgets and resources.

Overview

7
7
years of professional experience

Work History

Process Engineer

Univac Precision Engineering
05.2022 - Current
  • Provide technical assistance to production team when issues
    arose.
  • Reviews processes, identifying areas requiring improvement.
  • Conducts root cause analysis to identify, prioritize and eliminate process losses.
  • Participates in project reviews to enable ongoing status tracking and
    reporting.
  • Develops documentation, diagrams, and specifications to meet project requirements and regulatory standards.
  • Designing new products/processes, modifying and improving existing products/processes, developing test procedures.
  • Discuss with cross functional team to determine engineering feasibility, cost-effectiveness, and customer demand for new and existing products.
  • Drives engineering improvements, provide technical support, and lead initiative to achieve right quality of product within customer requirements and follow regulatory requirements standards.
  • Participate in design reviews for manufacturing equipment.
  • Performs installation, FAT/SAT, commissioning, optimization, and qualifying of new machines via IOPQ qualification and validation processes.
  • Proactively communicate project progress, key issues and any other critical topics in timely manner to appropriate management level and vendors and clients.
  • Lead, participate and support project/NPI such as line transfer & setup, process development.
  • Provide timely engineering support and solution, ensuring production line is running smoothly and meeting operational goal.
  • Work closely with production and customer to solve line quality issue.
  • Improve and ensure line processes are in control using SPC, Cpk, FMEA and other statistical tools.

Senior Application Engineer - Manufacturing

Racer Technology Pte. Ltd.
02.2019 - 05.2022
  • Assembly of Medical Devices, Skin care products, Electronic devices, Sub-assemblies of Electronic devices, Microfluidic Chips, Life sciences application products, IVD Products (Reagent and Test Kits), Surgical Face Mask Manufacturing
  • Manufacturing Line setup of auto/semi-automatic/ assembly by various assembly techniques
  • Works in NPI team for new products and projects and sources necessary facilities/process to make project start
  • Communicate with Clients/R&D Team to gather knowledge transfer from prototype development and makes it as cost effective manufacturability
  • Involves in process development, validation and training activities for new projects and new technology
  • Improves overall efficiency of assembly process by developing, updating and revising tools/equipment that ease manufacturability
  • Review Design for Assembly process and prepare PFMEA
  • Review and revise proposals for new product specifications or current specification modifications established by design documentation
  • Initiates and implementation Engineering Change Note (ECN/ECO/ECR)
  • Perform IOPQ Validation Process Activities for various Equipment used for Manufacturing Process, validate assembly process for medical devices and prepares validation documents
  • Prepares Manufacturing Documents (BOM, Work Instructions, Manufacturing Process Control Plan, Packaging Standards, Etc.) Provide required training to subordinates on new equipment, processes & procedures
  • Establish PM Checklist and Perform Periodic Preventive Maintenance for Equipment/Instrument
  • Arranges Instrument/Equipment for Third Party Calibration and review Calibration Certificate
  • Apply lean manufacturing and six sigma concepts and maximizes productivity
  • Prepares Device master record for class I and II medical products
  • Follow well established Quality procedures based on ISO 13485, ISO 9001, and ISO 14001 and FDA standards in Assembly line
  • Handles and prepares for ISO audits.

Senior Engineer - Production

SIDVIN PLASTECH PVT. LTD.
09.2016 - 02.2019
  • Production Engineer in manufacturing of medical devices and pharma packing materials
  • Processing of plastic products and packaging materials by using injection molding process and blown film extrusion process
  • Supports production process by resolving technical issues
  • Perform IQOQPQ for Molding Process Validation process
  • Assurance of quality of products to QA by following GMP
  • Analyze and select new processes, equipment for longer-term production
  • General Maintenance and Mould maintenance and services
  • Manpower handling and Production planning and follow delivery requirements.

Education

SDRA (Specialist Diploma Robotics and Automation) -

Temasek Polytechnic, Singapore
01.2023

B.E [Mechanical Engineering] - Mechanical Engineering

Shivani College of Engineering And Technology, Tamilnadu, India
07.2016

Skills

  • Process Development and Process Flow
  • Process Validation
    New Process Implementation
  • Equipment Optimization
  • Continuous Improvement
  • Team Collaboration
  • Documents and Reports
  • Project Management
  • Root Cause Analysis
  • Critical Thinking
  • Product Specifications Analysis
  • Complex Problem Solving
  • Vendor Collaboration
  • Statistical Data Analysis
  • Fabrication and Assembly Sequencing
  • Material Utilization Improvement
  • Technical Documentation
  • Technical Troubleshooting
  • Lean Manufacturing Processes
  • Cycle Time Optimization
  • Technical Presentations
  • KPI Monitoring
  • Inventory Control

Training And Workshops

  • Three days Inplant training at “HI-TECH ARAI Private Limited” a leading manufacturer of Oil seals and moulded rubber products.
  • One week Inplant training at “DIESEL LOCO SHED, Southern Railways, Golden Rock, Trichy.

Declaration

I hereby declare that the above information about me are true upto my known knowledge.

Projects And Presentations

  • Analysis of surface integrity of machined profile in CNC milling by using coated CAT40 tool holder.
  • Design and Fabrication of Angle Holding Double Jaw Vice.
  • Presented a Paper on the Topic of “BENEFICIAL ALTERNATION IN HYBRID CARS” at Karunya University, Coimbatore and Anna University BIT Campus, Trichy.

Additional Information

  • Medical Devices Assembly,
  • Life science products assembly,
  • Microfluidic Chip assembly,
  • PDMS Casting, Injection Moulding,
  • Compression Rubber molding, Plastic Processing,
  • Soldering, Ultrasonic welding, Heat sealing,
  • Hot Welding, Gluing Process, UV bonding,
  • Laser marking, Laser Welding Process,
  • Chemical filling and Auto Dispensing,
  • Pneumatic and Hydraulic Pressing, Punching and Forming,
  • Blown film Extrusion,
  • Project Management
  • Lean Environments

Timeline

Process Engineer - Univac Precision Engineering
05.2022 - Current
Senior Application Engineer - Manufacturing - Racer Technology Pte. Ltd.
02.2019 - 05.2022
Senior Engineer - Production - SIDVIN PLASTECH PVT. LTD.
09.2016 - 02.2019
Temasek Polytechnic - SDRA (Specialist Diploma Robotics and Automation),
Shivani College of Engineering And Technology - B.E [Mechanical Engineering], Mechanical Engineering
NILESH P