Vaibhav R Kumar
Bangalore
Summary
Systems Engineer and Agile practitioner with over 7 years of experience delivering end-to-end system solutions for innovative medical device development . Drives cross-functional teams, manages project timelines, and ensures high-quality solution delivery aligned with business objectives. Focuses on continuous improvement and stakeholder engagement to enhance project success.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Lead Systems Engineer
GE Healthcare
Bangalore, Karnataka
10.2023 - Current
- Working as a lead systems engineer for Maternal Fetal Care products such as Corometrics and Novii monitors.
- Led and coordinated crossfunctional teams, including hardware, software, regulatory, V&V, manufacturing, sourcing, and SQE, to ensure alignment and on-time achievement of project objectives.
- Managed projects on design changes and supplier transfers, ensuring alignment with operational goals.
- Developed comprehensive project plans, outlining scopes, timelines, and resources, facilitating smooth execution.
- Co-ordinated project schedules, milestones, and deliverables, ensuring timely completion within budget.
- Lead the team during FDA, MDSAP, and CDSCO audits.
- Formulated requirements, implemented design strategies, and developed test plans while tracing complex system, user, and safety requirements to subsystem modules, ensuring alignment and seamless integration.
- Presented project proposals and reports to senior management, articulating project value and securing necessary approvals.
- Worked in MDR projects for Resuscitation system and fetal monitors.
- Proficient in presenting RAC changes at the Risk Review Board and SPRs during design review meetings.
- Well versed with FMEA and Risk Management process and led risk assessment and managed risk files like CMT, RAC and RCA.
- Co-ordinated design & testing of applicable IEC standards and involved in gap assessments for new projects and product upgrades.
- Analysed supplier change requests with the support of engineering team.
- Engaged with customers to understand needs, providing tailored solutions to enhance service delivery.
- Identified issues, analysed information and provided solutions to problems.
- Took on additional duties to enhance overall team performance.
- Facilitated training sessions for junior engineers, enhancing skills and promoting a culture of continuous learning.
- Knowledgeable in ISO14971, ISO13485, IEC60601-1 and IEC62304.
IB & NPI Mechanical Engineer
GE Healthcare
Bangalore, Karnataka
10.2021 - 09.2023
- Managed life cycles of infant and fetal care products, including resuscitation devices, phototherapy devices, incubators, infant warmers, shuttles, and Corometric fetal monitors, ensuring alignment with regulatory standards and customer needs.
- Created innovative fetal monitoring product designs that meet performance, reliability, and customer requirements at competitive costs.
- Validated designs using mechanical calculations and finite element analysis (FEA) to ensure accuracy.
- Developed 3D CAD models for mechanical components using GD&T and performed tolerance stack-up analysis.
- Led mechanical re-spin project, enhancing reliability of hand-held devices through targeted design improvements and rigorous testing.
- Worked on design changes, ECR/ECOs and supplier changes on released products.
- Undertook verification and validation activities as part of the Install base team.
- Worked along with the manufacturing team in updating test specifications, making concessions and deviations for builds.
- Led investigations and NCs to closure successfully.
- Owned symptom, problem, cause, and resolution complaint coding activities for field products, facilitating timely responses to customer issues and contributing to product quality assurance.
- Supported in FMI recalls and service-related activities.
- Proficient in working along with various cross-functional teams and suppliers.
- Skilled in using tools like myworkshop, PQM, SQCS, compass, Appian, trackwise and windchill tools for product life cycle management.
- Experienced in using Creo and Ansys tools for design and analysis purposes.
IB Mechanical Engineer
GE Healthcare
Bangalore, Karnataka
06.2019 - 10.2021
- Partnered with internal and external stakeholders to establish product specifications, documentation, design, prototyping, and testing, successfully completing the conceptual design phase.
- Conducted root cause analysis for field-reported failures, leading to targeted design improvements.
- Drafted and released Feature Design Specifications (FDS) and Detailed Design Specifications (DDS).
- Presented Technical Design Reviews (TDRs) for design changes and NPI projects.
- Managed integration testing of sub-systems, identifying defects and implementing corrective actions.
- Developed test plans and generated test reports.
- Performed technical analysis, creating markups and validating assemblies and parts.
- Developed manufacturing Standard Operating Procedures (SOPs) and trained assembly team on efficient assembly practices.
- Planned and prepared assembly procedures, sequences, and BOM structures.
- Utilized Application Lifecycle Management (ALM) and Rally for project tracking.
- Collaborated with third-party vendors and global crossfunctional teams.
Education
M.TECH - CAD/CAM
VELLORE INSTITUTE OF TECHNOLOGY
Vellore01-2019
BE - MECHANICAL ENGINEERING
ST. JOSEPHS COLLEGE OF ENGINEERING
Chennai01-2017
Skills
- End-to-End Systems Design
- Requirement Management
- Risk Management
- Program management
- Project management
- FMEA facilitation
- Anomaly Management
- Product knowledge
- Cross-functional collaboration
- Technical Leadership
- Learning Agility
- Time Management
- Good communication skills
- Team Player
Certification
- Certified Scrum Master
- Yellow Belt in Design for Reliability from GEHC
- Trained by PMI on PMP
- Six Sigma Green Belt trained by GEHC
- Generative AI and prompt engineering - Beginners
Languages
English
Proficient
C2
Malayalam
Intermediate
B1
Tamil
Upper Intermediate
B2
Hindi
Upper Intermediate
B2
Hobbies and Interests
- Enthusiastic about participating in outdoor sports
- Actively engage in volunteer activities
- Proactively involved in organizing teambuilding and energizing events
- Fond of cooking
Custom Section
Hold a valid B1 Visa
Timeline
Lead Systems Engineer
GE Healthcare
10.2023 - Current
IB & NPI Mechanical Engineer
GE Healthcare
10.2021 - 09.2023
IB Mechanical Engineer
GE Healthcare
06.2019 - 10.2021
M.TECH - CAD/CAM
VELLORE INSTITUTE OF TECHNOLOGY
BE - MECHANICAL ENGINEERING
ST. JOSEPHS COLLEGE OF ENGINEERING