Summary
Overview
Work History
Education
Skills
Websites
Certification
Disclaimer
Hobbies and Interests
Personal Information
Timeline
Generic

Amit Pal

Bengaluru

Summary

Adept Senior Software Design Quality Engineer with a proven track record at NFERENCE (Anumana), showcasing expertise in risk assessment and quality assurance. Leveraged agile methodology to enhance product development, ensuring compliance with international standards. Demonstrates exceptional team leadership and document control skills, significantly improving project deliverables and compliance.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Senior Software Design Quality Engineer

NFERENCE (Anumana)
Bengaluru
04.2024 - Current
  • Assuring Quality in new product development and implementation of engineering changes to ensure that product changes are implemented as planned.
  • Assisted in completing deliverables that are in compliance with the Anumana quality standards and processes.
  • Utilized agile methodology for overseeing the team's task management through Smartsheet to track the status of the ongoing project.
  • Reviewing and approving new product quality documents (DDP, SDP, PRS, RMP, Risk File, Labeling Protocol, IFU, CM, V&V) to ensure they meet industry standards and current regulatory requirements.
  • Ensure documentation accuracy and completeness for all phases of the software development lifecycle.
  • Perform risk assessments to identify potential hazards associated with the software and implement appropriate mitigation strategies
  • Maintain and update Software as medical device risk management files throughout the product lifecycle
  • Supporting in Develop, review, and approve software verification and validation (V&V) protocols results and reports
  • Work closely with cross-functional teams, including software development, product management, and regulatory affairs, and clinical team to ensure Anumana quality objectives are met
  • Performed US FDA EUDA MED Predicate Device or Similar device complaint analysis for the New Product Development to get the input for Use related risk analysis to evaluate during Use FMEA Creation
  • Ensure compliance with ISO-13485, IEC-62304, FDA CFR21Part 820, ISO-14971, AAMI TIR-57, IEC 81001-5-1, latest regulation for AI/ML device and cybersecurity standard compliance
  • Participate in the Design Review Meeting for each phase of product development and be responsible for giving updates on all risks (medium or high) that occurred during the assessment related to SaMD.
  • Through the review of the product security testing protocol, cybersecurity plan, report, and product verification testing documents (unit testing, system testing).
  • Participate in the audit, review, and approve design control deliverables and changes to the Engineering Change Plan (ECR/ECO) on Greenlight Guru.
  • Updated existing documents based on standard assessment for EU MDR, and FDA.

Specialist

TATA Elxsi
Pune
09.2023 - 04.2024
  • Worked for DHF document Remediation and Creation of Design Verification supporting Documents Identification of Product specific test Gaps identification as per 21 CFR 820.30
  • Assisted in writing functional requirement in Product Requirement specification document, made requirement Traceability matrix (RTM)
  • Participation with team to do brainstorming to identify root cause and conclude custom
  • Worked for the creation of Dfmea, risk-benefit analysis and Template Migration of software products, risk evaluation based on severity of risks for Endoscopic Devices and Their Accessories
  • Worked for software as medical device development reviewing deliverables under dhf document and risk assessment for Electro-Medical System/ Digital health Devices
  • Statistical Test data analysis using MiniTab and used Power BI for insights visualization creation, sample size determination during Test method & Protocols creation

Lead Engineer

HCL Tech
Chennai
11.2021 - 08.2023
  • Lead a team of seven people for EU MDR gap assessments to verify and comply with electro-surgery legacy devices (electro-mechanical and implantable devices) with standard gap assessments such as IEC 60601-1, IEC 60601-2, ISO 14971, ISO 15223, and ISO 20417.15223, and ISO 20417
  • Worked on engineering changes, maintaining engineering documents, CAD drawing revisions, document uploads, and follow-up through PLM (Oracle Agile and MasterControl).
  • Created Documents - Design Verification & Validation Documents: DHF, DIOVV, Test Matrix, Requirement Traceability Matrix, User RTM, and Product RTM Document.
  • Participate in the electromechanical medical device risk management process and updates per ISO 14971 to ensure the safety and effectiveness of the product.
  • Participated in V&V process, continuous quality improvement activities, and ensured good documentation practices were followed in DHF documents.
  • Created PowerPoint slides as per design changes proposed for the design review meeting with the cross-functional team and presented with lead counterparts.
  • Utilized Power BI to develop a Team Dashboard that provides data insights regarding the current task progress in relation to the planned deliverables, categorized by product.
  • Conducted multiple training sessions through a brief presentation, focusing on product knowledge transfer and mentoring for associated team members.

Design Engineer

Oceanside (Mirus) Technologies
Gurgaon
11.2020 - 11.2021
  • Generate Concept and primary design based on the study of anatomy, biomechanical forces and pathology, Review of surgical technique, Guidelines
  • Assist in 3d printing and Prototype design
  • Made CAD Models drawings (Lumbar Plate, Posterior cervical Screw& Related Surgical instruments Design) on SolidWorks, Assembly and part drawing as per ASME Y14.5, applying GD&T on manufacturing drawings, Performed Static FEA using ANSYS 19.2
  • Aid in creation of Test method, and plan validation protocol as per ASTM 1717, ASTM F2077, ASTM F1798 Standards
  • Helped in developing the fixtures CAD Model test method for spinal implant developments
  • Worked for Various Lateral Surgery Related Instruments Design Implant insertor, Drill guide Supported in verifying all design/Assembly Dimensional analysis, (fitment and tolerance analysis)/ Performed 1D Stack up analysis
  • Created Collection of Design Input through Client, surgeons and competitive analysis, communication Daily/ weekly works Updates and Team quarries/ Doubts Discussions review sheet updates

Design Engineer

HW Transformation
Noida
04.2018 - 08.2020
  • Worked for creation of Part drawings/ Assembly drawings Welding symbols and other manufacturing symbols
  • Worked for Cad modelling, structure concept design and Maintain Product Bill of material on excel and communicating clients at manufacturing location
  • Designed different types of Supporting Platform, Handrailing for Stairs worked for cad model and Drawings of dust hood and Hooper for trimming machine
  • Worked on different weldment structure like Square Rectangle, Pipe for machine Foundation model and other different sheet metal product design
  • Performed client Drawing Review, Maintaining Bill of material through Excel record and other related data management
  • Use of Point cloud data (3d scan data), for Reverse Engineering to 3d Modeling Approach and Part Design and Detail drawings
  • New Part design, concept design

Engineer Trainee

Central Institute of Hand Tool
Jalandher
06.2016 - 12.2017
  • Learned many CAD Software like AutoCAD, Inventor, Solidworks, Creo, NX to give Training through Power Point Presentation of mechanical Product designing
  • Designed 2d drawing for machining water jet cutting machining operation for sheet metal cutting
  • Created mechanical Part design for micro medium and small enterprise for their Product development and improvement
  • Maintained Product designed packaged and Part file based on engineering changes happen to engineering hand tools

Education

B-Tech - Mechanical Engineering

Meerut Institute of Technology Meerut
Meerut
06.2016

12 th Class - Physics, Chemistry, Maths

AS Inter College
07.2012

10th Class - Science-Math

Janta Inter College Bana
06.2010

Skills

  • Software as a Medical Device (AI/ML)
  • Time management
  • Compliance standards
  • Risk Management - ISO 14971: 2019
  • Software Risk Assessment – AAMI TIR 57, 97
  • Quality Management System - ISO 13485, 21 CFR, EU MDR
  • HFE and Usability: IEC 62366
  • Agile methodology
  • Software development, SDLC, IEC 62304
  • Product Security/Cybersecurity Review
  • Test protocol review
  • CAPA, audits, and root cause identification
  • Technical documentation, problem solving
  • Software in medical devices: IEC 60601-1
  • Good Communication & analytical

Certification

  • Certification in Power BI & Business analytics with excel, Simplilearn
  • Master Certification in Data Science & AI, Simplilearn
  • Six Sigma Green Belt Certification, Benchmark
  • Basic Certification In Cybersecurity
  • ISO 13485 CQI/IRCA Lead Auditor Certification from TUV SUD

Disclaimer

I, Amit Pal, hereby declare that the information contained herein is true and correct to the best of my knowledge and belief.

Hobbies and Interests

  • Loves to Read articles, Read Article, News.
  • Love to Play Outdoor games e.g. (Cricket, Badminton), and doing Yoga.
  • Like to Travel and Explore new science and tech articles.

Personal Information

Date of Birth: 07/01/95

Timeline

Senior Software Design Quality Engineer

NFERENCE (Anumana)
04.2024 - Current

Specialist

TATA Elxsi
09.2023 - 04.2024

Lead Engineer

HCL Tech
11.2021 - 08.2023

Design Engineer

Oceanside (Mirus) Technologies
11.2020 - 11.2021

Design Engineer

HW Transformation
04.2018 - 08.2020

Engineer Trainee

Central Institute of Hand Tool
06.2016 - 12.2017

B-Tech - Mechanical Engineering

Meerut Institute of Technology Meerut

12 th Class - Physics, Chemistry, Maths

AS Inter College

10th Class - Science-Math

Janta Inter College Bana

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Amit Pal