Mohan

About Mohan

Experienced professional with 12 years in Verification & Validation, System Engineering, and Pre-Compliance Testing for Medical Device R&D. Expertise in Electrical, Mechanical, and Safety Compliance Testing for Medical, IT equipment, and Consumer Products, ensuring adherence to global standards like IEC, ISO, FDA, EUMDR, UL etc. Proven ability to drive quality and regulatory compliance in product development.

Experience

1. Verification and Validation Lead

   Erba Mannheim

   Jun 2023 — Present

   Execute, Perform, report out testing and pre compliance activities of Autonomous blood drawing device (NPD), Time Resolved Fluorescence Resonance Energy Transfer (TR-FRET) reader, Fully Automatic Clinical Chemistry Analyzer, Automated Coagulation device and other IVD projects.Verification & Validation of Medical Devices:1. Implements design for testability by collaborating with R&D (Research and Development) teams to evaluate requirements for testability. Collaborates with external agencies for compliance and safety certification.2. Provides engineering expertise in software and system verification and establishes system V&V plans, assists in developments of protocols and reviews reports.3. Incorporates essential operating mechanisms of systems engineering of medical device design and engineering principles and adheres to medical device regulations.4. Performs the role of a specialist by reviewing work products.5. Formulate the Verification strategy for a product/subsystem/Feature.6. Participates in Review of engineering deliverables (Ex: Requirements, Use cases, Risk Mitigations etc.)7. Supports in estimation, planning and risk management activities related to test activities.8. Lead test case development, review, execution, and reporting and traceability process on the responsible area.9. Ownership of Completeness of all test documents.10. Manages technical communication within team and partners/stakeholders.11. Participates in improvement initiatives to enhance productivity.12. Look for the opportunities of test automation in the assigned areas.13. Train and mentor other testers on domain and process.

Education

• Visvesvaraya Technological University

  Bachelor of Engineering - BE, Electrical and Electronics Engineering

Skills

• Matlab
• Project Planning
• Safety Compliance
• Engineering
• Industrial Electronics Control
• Management
• Electronics
• Microsoft Word
• Microsoft Office
• Autocad
• Automation
• Generators
• Microsoft Excel
• Project Management
• Testing
• Electrical Engineering
• Microcontrollers
• 8051 Microcontroller
• Switch Gears and Drives
• Basics of Plc and Its Applications
• Electrical Machines
• C++