Summary
Overview
Work History
Education
Skills
Certification
Gallup Top-5 Strengths
Accomplishments
Languages
Websites
Timeline
Generic

Ishan Kumar

Gurugram

Summary

Senior Staff Engineer at Stryker with a proven track record in leading V&V strategies for medical device software/system. Expert in design verification and validation, I excel in cross-functional collaboration and effective communication, driving successful regulatory submissions and enhancing product quality. Passionate about innovation and continuous improvement in healthcare technology.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Senior Staff Engineer

Stryker
Gurugram
09.2023 - Current
  • Leading Verification & Validation (V&V) strategy and execution for navigation-based medical device software.
  • Created comprehensive test plans, protocols, and reports for Class II/III medical device software.
  • Collaborated with cross-disciplinary teams (R&D, RA, AQE, Clinical science, marketing, Mechanical, PMO) to drive test alignment with system requirements.
  • Led a cross-functional test team across manual, automation, and system testing domains.
  • Providing technical leadership across cross-functional teams to ensure FDA and ISO 13485 compliance.
  • Supporting training initiatives for healthcare professionals (HCPs) and internal teams.
  • Authored and reviewed design verification documents, contributing to Design History File (DHF) and Technical File for regulatory submissions (FDA, EU MDR, TGA).
  • Supported & executed formative and summative evaluations with usability and marketing teams for early feedback from cadaver labs/simulations.
  • Presented testing metrics and release readiness to executive leadership and design review boards.

Staff Engineer

Stryker
Gurugram
03.2021 - 08.2023
  • V&V planning, execution, and documentation for advanced guided navigation systems.
  • Aligned product testing with ASTM standards, usability requirements, and international regulatory guidelines.
  • Acted as the primary liaison between engineering, quality, and regulatory stakeholders.

Senior Software Engineer

Stryker
Gurugram
07.2018 - 02.2021
  • Executed system, integration, and regression testing of surgical navigation platforms.
  • Led performance and reliability evaluations for software used in orthopaedic procedures.
  • Managed traceability of design inputs to verification outputs in support of FDA submissions.

Senior Quality Analyst

Collabera Inc.
Gurugram
11.2017 - 07.2018
  • Conducted manual and automated testing for web-based applications.
  • Contributed to software lifecycle processes and collaborated closely with development teams.
  • Reported and tracked issues using JIRA and supported continuous integration with Jenkins.

Test Engineer

Wipro
Noida
02.2011 - 03.2015
  • Developed and executed manual and automated test cases for enterprise applications.
  • Ensured adherence to SDLC processes, defect management, and agile test practices.
  • Gained foundational experience in quality assurance processes and client communication.

Education

Bachelor of Technology (B.Tech) - Electronics and Communication Engineering

Dr. A.P.J. Abdul Kalam Technical University
Lucknow, India
01.2010

HSC and SSC - Mathematics, Physics, Chemistry

Central Board of Secondary Education (CBSE)
01.2006

Skills

  • Medical Device Navigation and Robotics
  • JIRA & Agile JIRA
  • JAMA (Traceability)
  • OnePLM (Document control)
  • Perforce & GIT (Code check-in)
  • Jenkins (CI/CD)
  • System Testing (Functional & Non-functional)
  • GUI Testing (User feedback)
  • Regression Testing
  • Accuracy Testing
  • Design verification
  • Effective communication
  • Strong problem-solving skills
  • Systems engineering practices
  • Project estimation
  • Risk assessment
  • Performance Testing
  • Reliability Testing
  • Internationalization Testing
  • SDLC (Agile and V-Model)
  • ASTM Testing Standards

Certification

  • ISTQB Advanced Test Manager, Indian Testing Board, 01/25
  • Agile Testing, LinkedIn Learning, 06/20
  • ISTQB Foundation Level, International Software Testing Qualifications Board, 12/19, ITBP1335608

Gallup Top-5 Strengths

  • Relator
  • Communication
  • Includer
  • Responsibility
  • Positivity

Accomplishments

  • Employee of the Year 2022
  • Employee of the Quarter 2024
  • Conducted the organizational-level domain academy 2024

Languages

Hindi
First Language
English
Advanced (C1)
C1

Websites

Timeline

Senior Staff Engineer

Stryker
09.2023 - Current

Staff Engineer

Stryker
03.2021 - 08.2023

Senior Software Engineer

Stryker
07.2018 - 02.2021

Senior Quality Analyst

Collabera Inc.
11.2017 - 07.2018

Test Engineer

Wipro
02.2011 - 03.2015

Bachelor of Technology (B.Tech) - Electronics and Communication Engineering

Dr. A.P.J. Abdul Kalam Technical University

HSC and SSC - Mathematics, Physics, Chemistry

Central Board of Secondary Education (CBSE)

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Ishan Kumar