Quality Engineer: Test & CAPA Root-Cause

BESTIN SHAJI NALPAT

QUALITY ENGINEER — TEST, VALIDATION & CAPA ROOT-CAUSE

Wheeling, IL 60090 847-***-**** ************@*****.*** U.S. Citizen PROFESSIONAL SUMMARY

Electrical & Electronics Engineer with 6+ years of quality, test, and validation engineering in FDA-regulated medical-device and electronics manufacturing at Plexus (ISO 13485, 21 CFR 820, ISO 14971-aligned risk management), supporting Baxter, Medtronic, and Philips. Leads root-cause investigations and CAPA/OOT closure on customer, internal, and field failures; applies FMEA risk assessment; authors and approves IQ/OQ/PQ protocols, Validation Master Plans, and work instructions; validates measurement and test systems (Gage R&R, calibration); and partners with engineering, manufacturing, suppliers, and customers. U.S. Citizen.

CORE COMPETENCIES

Quality Engineering & Verification /

Validation

Risk Management (ISO 14971 / FMEA) IQ/OQ/PQ & Validation Master Plans

Test Automation (TestStand / LabVIEW) Customer & Field-Failure Analysis CAPA / OOT Root-Cause Investigation

Design Controls & Traceability Test-System Validation & Gage R&R Multi-Site Program Collaboration

Cross-Functional Technical Leadership Customer & Supplier Quality Liaison Operator/Technician Training & Direction

Regulated Manufacturing (FDA 21 CFR

820 / ISO 13485)

Capacity & Reliability Studies Equipment & Calibration Management PROFESSIONAL EXPERIENCE

PLEXUS CORPORATION — Buffalo Grove, IL & Neenah, WI Oct 2021 – Present Test Engineer

• Provide technical and quality leadership for verification, NPI, and production-test activities across multiple medical-device programs; direct technicians and operators and serve as primary technical liaison to customer engineering and quality teams, including Baxter, Medtronic, and Philips.

• Author, review, and approve verification protocols, IQ/OQ/PQ validation packages, Validation Master Plans (VMPs), and Assembly Build Instructions in accordance with FDA 21 CFR Part 820 and ISO 13485 quality system standards.

• Lead risk management consistent with ISO 14971: drive FMEA, Out-of-Tolerance (OOT) investigations, and Corrective/Preventive Action (CAPA) from hazard identification through mitigation and closure.

• Lead root-cause investigations and failure analyses on customer, internal, and field-returned product independently, presenting findings and corrective-action recommendations to engineering and quality stakeholders.

• Own test-system validation, Gage R&R repeatability studies, and capacity studies used to qualify production readiness for new and transferred product lines.

• Lead Engineering Change Order (ECO) implementation and RFQ/test-quoting activities; manage tooling, fixtures, and calibration across a 1,200+ unit equipment base.

• Develop technical work instructions and lead hands-on training for operators and test technicians, building repeatable, audit-ready test and inspection processes.

Baxter Spectrum Infusion Pumps — Patient Safety

• Lead repair, refurbishment, and system-level test engineering for Spectrum Infusion Pumps; verify safety, performance, and flow-accuracy specifications using PicoScope, Sigma Config, and F380.

• Spearheaded critical failure investigations on field-returned units associated with potential patient harm; performed system-level fault replication and executed site escape analysis to assess risk exposure and verify process safeguards. Baxter Nutrition / ExactaMix Display

• Led the technical transfer of PCBA test methodology for the ExactaMix Display following component end-of-life, including on-site collaboration with Eurotech (Maryland) and Baxter R&D, Quality, and Manufacturing Engineering to finalize test architecture and resolve competing constraints.

• Directed implementation, documentation, and operator/tester training for the transferred test process at Plexus. Philips HPM — Multi-Site & Test Automation

• Partnered with the Plexus team in Neenah, Wisconsin to implement system-level testing for Philips HPM projects, coordinating verification activities across both facilities.

• Utilized NI TestStand and LabVIEW to run, troubleshoot, and validate test systems; verified automated data transfer into the Plexus Data Acquisition System for real-time quality analytics.

• Authored technical guidebooks/work instructions and led hands-on training for test technicians and production line operators.

Medtronic Hugo Surgical Robotic System

• Support system-level troubleshooting and verification for a next-generation surgical robotic platform under Class- appropriate regulatory controls.

• Coordinated a controlled inter-facility system transfer, managing verification and validation continuity across sites in accordance with QSR and SOP requirements.

Evolv Express & Fleet Geode

• Developed end-to-end work instructions covering standardized assembly, testing, and shipment readiness for Evolv Express security systems.

• Installed GNSS repeaters on site, verified satellite connectivity, and resolved complex system-level RF/network connectivity issues for Fleet Geode.

PLEXUS CORPORATION — Buffalo Grove, IL May 2020 – Oct 2021 Test Technician

• Conducted root-cause investigations and defect analysis on Baxter Spectrum Infusion Pumps; verified safety, performance, and flow accuracy using PicoScope, Sigma Config, and F380.

• Compiled investigational summaries, corrective actions, and device/service-order documentation. EDUCATION

B.S., Electrical & Electronics Engineering — Calicut University, India 2018 TECHNICAL SKILLS & CERTIFICATIONS

• Automation & Software: NI TestStand, LabVIEW, Data Acquisition Systems (DAS).

• Testing / Diagnostic Tools: PicoScope, Sigma Config, F380, Multimeters, Oscilloscopes.

• Engineering / Programming: MATLAB, C, C++, gEDA, Arduino.

• Quality / Validation: root-cause/failure analysis, FMEA, CAPA, OOT, IQ/OQ/PQ, VMPs, ECO, RFQ, Gage R&R, calibration, repeatability/capacity studies, design controls.

• Quality Standards: ISO 13485, FDA 21 CFR Part 820.

• Certifications: Foundations of Project Management; Project Initiation; Negotiation Foundations; Financial Acumen. SELECTED ACADEMIC PROJECTS & PUBLICATION

• Single Converter Based Solar High Mast Lighting — Designed circuit architecture in MATLAB and verified output voltage/current; Best Paper Award, National Conference on Emerging Research Trends in Electrical Engineering (2018); published in Global Research and Development Journal.

• Automated Irrigation System — Designed/assembled circuits and tested system output against preliminary design specifications.

ADDITIONAL EXPERIENCE & LEADERSHIP

• Treasurer, National Service Society (NSS) — Managed finances and organized community initiatives.

• Technical internships: Kerala Lakshmi Mills; Traco Cable; TELK; Government of Kerala Hydro Plant.

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