Aditya Gokhale
Plano,TX
Summary
Electrical Engineer with 8+ years of experience in regulated medical devices, specializing in implantable and system-level electrical integration. Led electrical activities across Class II/III platforms, supporting design verification, sustaining engineering, and IEC 60601 compliance. Experienced in supplier change impact assessment, risk management (ISO 14971), and global regulatory support within highly controlled environments.
Overview
13
13
years of professional experience
Work History
Electrical Enginner (Product Sustenance)
Abbott Neuromodulation
Plano, TX
02.2021 - Current
- Directed electrical engineering efforts supporting EU MDR approvals for implantable pain therapy systems and trial stimulators, including both primary cell and rechargeable IPG platforms.
- Served as R&D Electrical lead for 50+ Supplier Change Requests (SCR/SCN), evaluating impact to IPGs (primary cell and rechargeable), leads, and system-level components.
- Owned electrical execution of primary cell IPG battery change initiatives, assessing system performance, longevity, safety margins, and compliance implications.
- Defined and executed Electrical Safety, EMC, and ESD strategies under IEC 60601 standards across Neuromodulation platforms.
- Resolved compliance failures through structured root cause analysis and targeted corrective actions.
- Strengthened electrical risk documentation for implantable systems per ISO 14971, ensuring clear linkage between hazards, mitigations, and verification evidence.
- Provided technical leadership for global regulatory submissions (FDA, EU, TGA, PMDA, Health Canada), supporting defensible engineering justification.
R&D Test Engineer
Medtronic Neurosurgery
Louisville, CO
10.2018 - 12.2020
- Worked on 5+ product families for EUMDR and DHF remediation with responsibilities like Gap Assessment, creating Verification and Validation Plans/Summaries (VVP/S), Reviewing product requirements for Testability.
- Held Gap assessment and VVP reviews with stakeholders.
- Extensively worked with Systems Engineering team while developing Product Definition & Requirements (PDR) document per ISO 13485 and ISO 14971 and helped them trace requirements.
- Developed and executed hardware testing protocols for spine and cranial devices to meet product requirements.
- Authored Verification reports with detailed analysis, necessary attachments, etc., Bio-compatibility reports for non-patient contacting and invasive devices per ISO 10993.
- Heavily involved with Principle Microbiologist in Materials of Concern verification for products under consideration per CalProp65, REACH, EU RoHS, China RoHS, EU Packaging, EU POP, Health Canada, etc.
- Extensively read device drawings, schematics and Bill of Materials (BOM).
- Worked with third party vendors for completing Electrical Safety, Electromagnetic Compatibility (EMC) and Electrostatic Discharge (ESD) testing per IEC 60601 standards.
- Reviewed and approved PDRs, Change Effect Analysis (CEAs), Design Verification Testing (DVT) protocols and reports in PLM within project.
- Communicated with stakeholders weekly on project updates and any setbacks that might halt the project in the future for quick turnaround.
R&D Electrical Engineer
Allengers Medical Systems
Pune, India
06.2013 - 12.2015
- Assisted in developing electrical test strategies and verification plans for diagnostic and imaging equipment such as ECG, EEG, and C-arm systems.
- Developed and executed functional and safety test cases for prototype and pre-production configurations per internal quality and design control standards (aligned with ISO 13485).
- Collaborated with cross-functional teams (Electrical Design, Quality, and Manufacturing) to define measurable acceptance criteria for electrical subsystems.
- Performed electrical subsystem testing, data collection, and reporting for power distribution, signal integrity, user interface electronics, and safety performance.
- Supported materials evaluation and compliance for electrical/electronic components used in diagnostic systems.
- Contributed to verification documentation (test results, deviations, traceable records) to support product design files and production readiness.
- Assisted in packaging validation activities to ensure electrical equipment protection in shipping and field environments, aligning with ASTM standards.
Education
Master of Science - Electrical Engineering
Texas A&M University Kingsville
Kingsville, TXMaster of Science - Project Management
University of The Cumberlands
Williamsburg, KYBachelor of Engineering - Electronics And Telecommunication
Sant Gadge Baba Amravati University
Amravati, IndiaSkills
- Electrical Systems Integration
- Implantable Medical Devices (Class II/III)
- Design Verification & Validation (DVT)
- IEC 60601 (Safety, EMC, ESD)
- ISO 14971 Risk Management
- EU MDR & Global Regulatory Support
- Supplier Change Impact Assessment (SCR/SCN)
- Battery Systems (Primary & Rechargeable IPGs)
- Root Cause Analysis & Compliance Troubleshooting
- Product Lifecycle & Change Management
- Windchill PLM / HP ALM / JIRA
- Minitab (Statistical Analysis)
Timeline
Electrical Enginner (Product Sustenance)
Abbott Neuromodulation
02.2021 - Current
R&D Test Engineer
Medtronic Neurosurgery
10.2018 - 12.2020
R&D Electrical Engineer
Allengers Medical Systems
06.2013 - 12.2015
Master of Science - Electrical Engineering
Texas A&M University Kingsville
Master of Science - Project Management
University of The Cumberlands
Bachelor of Engineering - Electronics And Telecommunication
Sant Gadge Baba Amravati University