Vincent Valentine Email and Phone Number

-Company expert and SME for medical device / IVD risk analysis requirements, including usability, software, user safety, patient safety, and cybersecurity. Develop, implement and lead risk analysis activities and associated sub-tasks (hazard identification, risk evaluation, human factors hazards analysis per IEC 62366-1, software hazards analysis per IEC 62304, FTA, FMEA, etc.) on molecular diagnostic IVD medical devices and accessories in product development, per FDA requirements and ISO 14971:2019. Develop safety design inputs (requirements, specifications & risk control measures) to ensure new designs support overall patient safety, user safety and cybersecurity requirements. Ensure IVDR 2017/746 GSPRs and related risk requirements are met.-Plan, develop and manage reliability programs and associated sub-tasks including Quantitative Accelerated Life Tests (QALT), Highly Accelerated Life Tests (HALT), Reliability Growth Tests (RGT) and Reliability Demonstration Tests (RDT) on IVD medical instruments, modules and components in product development. Develop reliability design inputs (requirements & specifications) to ensure new designs support overall product reliability requirements. -Perform detailed reliability predictions, accelerated degradation life-stress mathematical modeling, reliability growth modeling and reliability allocation of systems, subsystems/modules and components utilizing diversified modeling and prediction tools (ReliaSoft, ALTA PRO, Weibull++, RBD, RGA PRO, etc.)-SME for safety standard compliance, EMC compliance, reliability, risk analysis and cybersecurity. Intimate knowledge of IVD standards that support electromechanical, software, architectural and safety design requirements for CE Marking, FDA approval and CB certification.

-Oversee design for reliability (DFR), design for testability (DFT) and design for manufacturability (DFM) activities for a wireless implantable continuous glucose monitoring system (CGMS). Perform complex failure investigations to determine root cause for failure modes associated with the CGMS system.-Translate FDA, FCC, AIMD and customer requirements into verifiable product requirements, specifications and test cases-Lead the risk analysis, reliability testing, HALT, safety and EMC testing of the glucose monitoring system's wireless implantable sensor and wireless receiver. Identify and implement electrical, mechanical and software design improvements to ensure optimal reliability, EMC and safety compliance.-Perform DFMEA and PFMEA of wireless implantable sensor

-Electrical design and development of life-support Intracranial Pressure (ICP) Monitors that work in conjunction with optical/fiber-optic pressure sensors and temperature sensors inserted into the brain.-Schematic capture, PCB layout, BOM generation, prototype development and validation of analog and digital patient-isolated electrical designs.-Electronic and electromechanical component reliability testing and safety testing per relevant medical device safety standards.-Lead technical resource for UL, FDA and CE-Marking approvals as well as Technical Files, DMR, DHF and FDA submissions for ICP monitoring systems under product development.-Identify, implement and validate implantable sensor reliability improvements. Perform detailed failure investigations for intracranial pressure systems and ultrasonic aspirator products.-Top level design of electrosurgical based ultrasonic aspirator.

-Concept, feasibility and prototype development and construction of temperature and power controlled Radio Frequency (RF) electrosurgical generators for start-up companies. Electrical design and development of commercially successful RF-based medical devices utilized for liver tumor ablation & cardiac ablation (Boston Scientific), cosmetic tissue remodeling (Thermage), pain management (Stryker), endometrial ablation (Valleylab), and permanent contraception device (Adiana).-Electrical design for electrogram (EGM) and electrocardiogram (ECG) intracardiac mapping system for targeted cardiac ablation. Schematic capture, PCB layout and validation of electrical designs.-Hardware and software development of complex automated test fixtures and systems to verify product functionality and characterize product reliability.-Risk analysis, reliability testing, specifications development and validation of various RF based products

-Electrical and software design and development for neonatal diagnostic infant hearing screener (Algo-1) utilizing auditory brainstem response (ABR) and auditory evoked potential (AEP) technologies.-Electronic and mechanical design and development of prototype high reliability ECG-triggered pulse oximeter utilizing fiber optics in conjunction with multi-wavelength laser diodes. -Electrical design and development of a portable end-tidal carbon monoxide (ETCO) breath analysis instrument/capnometer for early diagnosis of neonatal jaundice