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siddhesh ghanekar

@siddheshghanekar

I build and validate diagnostic instrumentation, from PCR cartridges to CBC analysers, with ISO 13485-focused documentation.

India

Message

What I'm looking for

I'm looking to build and validate regulated diagnostic or instrumentation products, contributing to verification, risk management, design documentation, and quality-focused development alongside QA and RA teams.

I'm designing and validating PCR cartridges and CBC analysers at Sciverse Solutions, integrating optics, imaging systems, thermal cyclers, and microfluidics. I execute IQ/OQ/PQ, VTP, VTR, DVP, and test plans within ISO 13485-oriented development practices.

I prepare traceability matrices, DHF support documents, validation records, and compliance documentation, while collaborating with QA and RA teams on audit preparation and CDSCO activities. I also support DFMEA, risk assessments, CAPA investigations, and engineering-change documentation.

Previously, I helped advance sodium-ion battery technology from TRL2 to TRL9 and led development work for a flywheel energy storage system. My work spans materials characterization, electrochemical validation, microfluidic deposition systems, and reproducible test protocols.

Experience

Work history, roles, and key accomplishments

Current

Instrumentation Scientist

Current

Sciverse Solutions Pvt. Ltd.

Oct 2024 - Present (1 year 11 months)

Designed and validated PCR cartridges and CBC analysers integrating optics, imaging systems, thermal cyclers, and microfluidics. Executed Verification & Validation activities including IQ/OQ/PQ, VTP, VTR, DVP, and test plan execution aligned with ISO 13485-oriented development practices.

Microfluidics Optics Imaging Systems Thermal Cyclers ISO 13485 CAPA Validation CDSCO