Senior Systems Engineer with excellent knowledge of Measurement, Testing, Validation and Verification flows

Jayne – Senior Systems Engineer

Responsible for upgrading and converting Offline/manual equipment and tools to Online/automated using SECS/GEM communication interface.
Responsible for designing, evaluating and analyzing hardware failures in high level test systems and electronics devices.
Failure mode, effects, and critical analysis of the products (FMECA), based on the 6 sigma standards, Lean Manufacturing and IEC 60601-1 standards for governing electrical characteristics for medical devices (Eigen). Gained a strong background in and is proficient in high and low volume manufacturing, plant and production process development, design, validation, verification, testing, electrical engineering, manufacturing modules, quality and industrial engineering.

Excellent knowledge of functional Measurement (Metrology), Testing, Validation and Verification flows
Performed the EMI/EMC analysis, design and verification, includes MTBF, failure mode, effects, and critical analysis of the products (FMECA)
Experienced and involved in DMAIC Six Sigma process improvements principles used for improving, optimizing and stabilizing business processes and designs.
Filing FDA 510k documentations, ISO13485 and CE Marks.
Architecture/Micro Architecture Design and Computer Hardware & Software Packages
Electrical design of imaging/ medical equipment (also test jigs design) and HW/SW test planning, setup and execution
Component circuitry and interconnection harness design and prototyping
Work flow design, equipment operation, troubleshooting and repair
Experienced in MRP, ERP and all ISO procedures 9001:2000 or equivalent QMS, also FDA's IEC 60601-1 standard, GMP's