Engineering Domains

Leads manufacturing system design and optimization across SMT, catheter assembly, and electromechanical device production, including fixture development, selective solder tooling, and functional test platforms. Drives production transfers and line readiness through capacity analysis, yield improvement, labor optimization, and equipment qualification. Delivers DFM/DFA solutions, supports NPI and sustaining engineering, and integrates automation to improve first-pass yield, uptime, and throughput in GMP-regulated environments.

Develops and executes comprehensive validation strategies for equipment, test methods, and manufacturing processes in compliance with ISO 13485, FDA QSR, and GHTF guidance. Authors Validation Plans, URS/FRS, and IQ/OQ/PQ/TMV protocols and reports for CNC machining, AOI systems, extrusion lines, cable testers, and functional test stations. Applies risk-based sampling, statistical analysis, and traceability to ensure sustained process capability and audit readiness.

Designs and validates automated and semi-automated test systems incorporating PLCs, HMIs, vision inspection, leak detection, and electrical safety testing. Develops electromechanical fixtures, test application code, and data acquisition workflows for ICT, functional test, and cable verification platforms (e.g., Agilent i3070, Cirris). Performs FAT/SAT, code reviews, and system integration to ensure reliable defect detection and regulatory compliance.

Leads end-to-end process development for medical device manufacturing, including extrusion, bonding, assembly, and inspection operations. Executes DOE, capability studies, and PFMEA updates to qualify new materials, suppliers, and process windows. Supports pilot builds through production scale-up, establishes control plans, and delivers validated, production-ready processes aligned with customer and regulatory requirements.

Performs software verification and validation for embedded and test system software in accordance with IEC 62304 lifecycle requirements. Supports EEPROM programming, PLC/HMI logic, vision system configuration, and data integrity controls. Conducts code reviews, functional testing, and traceability assessments to ensure software-hardware integration meets safety, performance, and regulatory expectations.

Executes risk-based quality engineering activities including CAPA investigations, FDA remediation, PFMEA/DFMEA updates, and measurement system validation. Leads root-cause analysis for production and inspection failures, supports audit responses, and ensures corrective actions are statistically verified and sustainably implemented. Partners with manufacturing and design teams to strengthen process controls and maintain continuous compliance.