- Experienced biomedical engineer with strong approach in test control, restructuring and managing quality assurance in testing processes for continuous improvement in test management tasks & product quality in organizational projects.
Quality: Root Cause Analysis, Pareto Chart, Process Maps, Ishikawa diagrams, DMAIC, ISO13485, ISO14791, 21CFR.
Software Testing: Test Planning, Software Requirement Analysis, Citrix, IBM Rational DOORs, Defect tracking, Design of Experiments, Agile Methodology.
Documentation: Project Documentation, Test Design, Design History File.
Computer Tools: Notepad++, MS Office, Arduino IDE, Eagle, Basics of Python, Basics of MATLAB, C#.
Certifications: Six Sigma Yellow Belt, Six Sigma Green Belt, Introduction to R programming, ISO13485:2016 - Awareness on Medical Device Development, Root Cause Analysis.
- Served as a seam between manual and automation team to ensure accuracy of design and test script in C#.
- Executed automated integration and regression testing for class III medical device i.e., pacemaker and ICD’s programmer application.
- Assessed test script and document into AccuRev SCM Application. Linked test scripts steps to requirements using IBM Rational DOORS tool. Compiled, assessed, planned, and analyzed defects involved using ClearQuest while uplifting automated test environment.
- Maintained traceability matrices for future references while validating effort plan to prevent defects and balance internal and external validation.
- Worked closely with clinical application SMEs to describe test strategies and provided feedbacks.
- Collaborated with cross functional teams for requirement analysis and maintained compliance with Quality Control standards on par with ISO 13485 and ISO14791 as well as IT strategy.
- Understanding project tasks with team brainstorming sessions to reduce errors in test runs to analyze client’s automation tool, mentored other team engineers on projects with medical terminologies.
- Participated in daily Scrum meetings, sprint planning, and process improvement.
Sales Application Manager
- Visited hospitals and clinics on service requests to analyze medical equipment breakdown and ensure that the instruments are working as desired.
- Gathered requirements on medical products in coordination with doctors and trained professionals.
- Supervised and managed a team of 4 engineers over day-to-day operations involving client visits and service calls.
- Performed market research to understand industry specific details and identified potential leads for medical instruments.
- Maintained Zoho CRM records to keep track of the customer’s requirements and established cordial relationship with the clients.
- Customized proposals after assessing client’s necessity, answered customer’s queries, and formulated reports on payments and call logs.