Ankit Yadav

About Ankit Yadav

Mechanical engineer with more than 6 years of experience in Medical Device and Automotive industry working on New product Development, Design Transfer and Risk Management seeking a full-time position. Proactive team player with expertise in Risk Management, CAD modeling, Design Controls, Design History Files (DHF), Tolerance Stack-up Analysis, CAPA, Change Control Management, and Risk Management conforming to ISO 13485 and ISO 14971.· Worked extensively on the Design Verification activities to verify the Design Input requirements.· Experience in Design Verification Testing for the Implantable medical devices.· Experience with EUMDR regulations, Design history file, Remediation of orthopedic system, change management system using CMS software, CAPA system, NCR review and analysis, PFMEA, DFMEA· Involved in Process Validation and Test Method Validation (TMV) including destructive and non-destructive methods using Nested and Crossed Gage R&R analysis.· Experienced in analysis of data for Gage R&R using statistical tools as Minitab.· Experience in Process Development conducting Proof of Concept Studies, Design of Experiments (DOE), Statistical studies (SPC) and experience in CAPA and GAP analysis.· Experience in 2D and 3D modeling using SolidWorks, NX 8.5, CREO 2.0, and AUTOCAD including expertise in Geometric Dimensioning and Tolerances (GD & T) in accordance to ASME Y 14.5 standards· Strong ability to lead teams to achieve project goals with designing skills in R&D, product planning and development, and project management and analytical and mechanical aptitude to deliver the product deliverables.· Expertise in Design Controls, Design History Files (DHF), Remediation, and Gap analysis. Performed updates to DHF, design inputs/outputs and product specification as applicable (from detailed Gap assessment).· Reviewed Design History Files to follow medical codes and procedures for New Product Development (NPD) & Sustaining Business.· Knowledgeable in CAPA systems, NCR review and analysis, Change Control Management, and Risk Management conforming to ISO 13485 and ISO 14971, FDA (21 CFR part 820 11)· Experience in Process Development conducting Proof of Concept Studies, Design of Experiments (DOE), and Statistical studies (SPC).

Experience

1. Sr Design Quality Engineer

   Waters Corporation

   Nov 2022 — Present · Boston, MA, US

   Participate in new product development projects by providing technical quality engineering support for assigned projects. Ensure engineering and scientific analyses are employed and design history files comply with company policies and applicable standards and regulations. Transfer knowledge of inherent product design risks and mitigating controls resulting from the design process to colleagues.* Key deliverables include but are not limited to performing previous product analysis on similar products and risk management activities. Supporting project team activities for requirements management, design reviews, design verification, design validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.*Facilitate Risk Management activities according to company policy, procedures and ISO 14971, including Risk Management Planning, Preliminary Hazard Analysis, FMEA, Software Risk Analysis, Risk Management Report and Risk Management File.* Act as Quality signatory on Product Development deliverables ensuring that company and departmental objectives are met.* Monitor Projects, PIM Investigation Tracker, ECR’s, Deviations, Defect Tracking Systems and First System Install Reviews to identify product quality trends and translate this information into improved product designs. Facilitate and participate in Root Cause Analysis of identified product and process deficiencies initiating system corrective actions as required.* Provide interpretation and guidance on industry best practice and state of art for design assurance activities. Work with global Design Quality Assurance peers and Product Development stakeholders to identify and develop improved or harmonized Product Development processes/systems and drive implementation within the relevant development areas.

Education

• Swami Vivekanand college of Engineering

  Bachelor of Engineering (B.E.), Mechanical Engineering

  2007 — 2011

• Wayne State University

  Master’s Degree, Mechanical Engineering

  2015 — 2017

Skills

• Research
• Simulations
• Geometric Dimensioning & Tolerancing
• Strategic Planning
• Mechanical Engineering
• Autocad
• Management
• Public Speaking
• Finite Element Analysis
• Continuous Improvement
• Catia
• Customer Service
• Microsoft Excel
• Powerpoint
• Hypermesh
• Engineering
• Microsoft Word
• Failure Mode and Effects Analysis (Fmea)
• Leadership
• Abaqus
• Manufacturing
• Computer-Aided Design (Cad)
• Microsoft Office
• Cae
• Project Management
• Ls-Dyna
• Matlab
• Product Development
• Product Management