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, India01.2010
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
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)