Vinoth Neelakandapillai
Senior Systems Engineer | Supplier Quality Engineer | ISO 13485 Auditor | Medical Devices | Process Validation | ISO 13485 | EU MDR | Risk Management |Six Sigma Greenbelt
- Role
- Senior System Engineer (Pay Role of Cyient) at Philips
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Vinoth Neelakandapillai
I don\'t just engineer medical devices. I make sure they reach patients. In 11…
Experience
Senior System Engineer (Pay Role of Cyient)
Nov 2024 — Present · Pune, IN
System Engineering & Architecture• Lead full lifecycle system engineering for Class Sleep and Respiratory Care (SRC) medical devices, including CPAP, BiPAP, and ventilator platforms, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820.• Architect system-level solutions integrating electromechanical components, embedded software, pressure control loops, flow sensors, and alarm mechanisms; optimized system performance across latency, accuracy, and safety KPIs.Requirements Management & Regulatory Compliance• Define, document, and manage system-level requirements, use cases, and traceability matrices using tools like IBM DOORS and Polarion, aligning with clinical use cases, ISO 14971 risk management, and regulatory expectations.• Lead cross-functional coordination between R&D, clinical, regulatory, and manufacturing teams to ensure timely product releases, technical file readiness (EU MDR), and comprehensive design control documentation (DHFs, DMRs).Clinical Integration & Collaboration• Translate clinical therapy requirements into formal engineering specifications by engaging with pulmonologists, respiratory therapists, and human factors teams to ensure patient-centric design.Problem Solving & Risk Mitigation• Drive root cause analysis (RCA) and corrective/preventive actions (CAPA) for post-market field issues using structured problem-solving tools (5 Whys, Fishbone, FMEA), enhancing product reliability and regulatory complianceProcess Optimization & V&V• Apply Lean Six Sigma methodologies (e.g, Value Stream Mapping, DMAIC) to streamline system integration, verification, and validation (V&V) activities
Education
Mani higher secondary schools
SSLC
2005 — 2009
Coimbatore Institute of Technology
diploma, Mechanical Engineering
2009 — 2012
Karpagam Academy of Higher Education, Coimbatore
Bachelor's degree, Mechanical Engineering
2014 — 2017
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