Matt Kas

Matt Kas

Product Quality Engineer

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  • Timeline

  • About me

    Quality and Reliability Engineer Medical Devices

  • Education

    • University of Illinois Chicago

      -
      M. S Materials Engineering
    • University of Illinois Chicago

      1990 - 1992
      Master's degree Electrical and Electronics Engineering
    • University of Illinois Chicago

      1988 - 1990
      Master's degree Materials Engineering
    • Orta Doğu Teknik Üniversitesi

      -
      B. S Metallurgical Engineering

      Activities and Societies: ASQ

  • Experience

    • De Amertek Corporation Inc

      Jan 1992 - Jan 1994
      Product Quality Engineer

      Launched products w/ APQP using QS9000 to customer's satisfactionDeveloped, implemented and maintained quality systems and activities for QS9000 and Military Application contractsDefined and specified implementation of standards, and procedures for inspecting, testing, and evaluating precision, accuracy and reliabilityTrained operators and technicians on hand soldering and SPC Performed continuous process improvement in thick film Hybrid processingServed as Customer Interface/Response- Root Cause Corrective ActionsDrove Statistical Process Control diagnostic activitiesImplemented quality audit programs and maintain quality system documentationSurveyed Supplier Quality Processes for Vendor rating & Corrective Actions Show less

    • Motorola

      Jan 1994 - Jan 2003
      SENIOR PRODUCT RELIABILITY / COMPONENT ENGINEER

      Managed multiple projects and applied DOE techniques for continuous improvementsAnalyzed Process Capability of CDMA Phones launching on time Collaborated w/ development driving corrective actions for achieving 6 sigma Performed reliability analysis w/ Weibull determining failure modesDeveloped reliability techniques for early failure detectionPerformed benchmarking on components improving product life cycleConducted predictive reliability techniques for base station componentsPerformed failure & construction analysis on Sensors, ICs, ECUs and PCBsAssisted plant during pilot production and production launch w/ DOE & FMEAPrepared customer responses, ECNs, specs and QS 9000 implementationCollaborated w/ customers & suppliers driving corrective actions for failuresRecommended design changes improving product reliability Show less

    • Onsemi

      Jan 2004 - Jan 2011
      SENIOR PRODUCT RELIABILITY QUALITY ENGINEER

      Provides product qualification plans and reliability risk assessment Establishes criteria for product qualification based on intrinsic and extrinsic reliability testing and suitability for use in the intended customer applicationInterfaces with new product development and manufacturing engineering technologists on projects requiring reliability qualification and (IPDS)Builds reliability plans with reliability lab personnel, monitors results, makes disposition of failures, and publishes reliability reports.Represents On Semi at JEDEC JC14 Reliability MeetingsPrepares responses/quality data to the customers Show less

    • GE HealthCare

      Dec 2010 - Aug 2011
      Quality Engineer

      • Worked as Contractor Senior Quality Engineer on GE Ultrasound Sensors performing standard Quality Engineer duties including MRB (Material Revision Board), CRB (Change Revision Board)• Performed internal audits as a Lead Auditor per • ISO 9001 13485, CFR820

    • Cameron Health

      May 2011 - May 2012
      Principle Reliability Engineer

      Principle Reliability Engineer in Medical Industry, Implantable DefibrilatorsPerforms design reliability analyses, including reliability mathematical models, allocations, and predictions and updating these with field performance data.• Designs and Performs Reliability Testing such HALT/HASS and Environmental Testing• Provides expertise and guidance in defining plans and executing standard reliability analysis, accelerated testing methods, environmental stress screening, and Design of Experiments• Recommends corrective actions based on failure analysis investigation results as necessary. • Performs root cause analysis, including data analysis (mining), identifying trends (systemic issues), and common cause issues for systems, peripherals, software, and components.• Participates in product risk analyses discussions, including: Failure Modes, Effects, and Criticality Analysis (FMECA), Fault Tree Analysis (FTA), and System Risk Analysis.• Assists in evaluating product design verification and component qualification test; protocols, especially with regard to sample size, test power, and related statistics.• Supports and guides medical device quality control activities, including: PFMEA, IQ/OQ/PQ, process capability, gauge R&R, and SPC. Show less

    • Masimo

      May 2012 - Mar 2015
      Senior Reliability/Quality Engineer

      Medical Device Reliability and Quality Engineering including below:• .Performs design reliability analyses and testing with Highly Accelerated Life Testing on Masimo monitoring devices such Pulse Oximeter• Performs Mean Time Between Failures Reliability Analysis on Masimo Instruments, Boards and components• Performs failure analysis activities which have typically been escalated from Technical Services, with the intent of isolating reported issues to the component or process level.• Leads product risk analyses, Nonconformance Requests and Design History Files• Provides Quality engineering support in new product development, technical manufacturing sustaining support, equipment/device qualification and process validationWork with Product Marketing to determine product use models and customer usage conditions for defining system, subsystem/module and component reliability requirements• Perform reliability allocation of subsystems and components to guide Product Development in achieving system level reliability requirements.• Performs reliability demonstration tests and analyses to validate that reliability requirements are met.• Manages on-going reliability testing (ORT) during production to monitor and ensure ongoing reliability performance of systems, modules and accessories.• Analyses field returns data to correlate and validate field reliability with in-house reliability life testing to drive continuous reliability improvements.• Provides expert guidance to drive improvements on reliability matters and testing such as reliability allocation and reliability calculations and analysis.• Participates in design reviews and phase gate reviews to provide inputs to validation and verification testing and interpretation of test results. Show less

    • Fluidic Energy

      Mar 2015 - May 2016
      Senior Reliability Engineer

      • Developed test plans based on specifications to validate Zinc –Air Rechargeable and Li-Ion Battery product life and reliability in order to successful launch of product• Supported quality and production goals by promptly and effectively managing activities such as initial design and qualification, customer/field issues resolution, root cause analysis, enforcement of preventative/corrective actions• “Data mining”: analyzes engineering test data, historical data, and field data to reduce validation test efforts and predict product reliability Show less

    • Ulthera, Inc., Merz Device Innovation Center (MDIC)

      Jun 2016 - Mar 2018
      Senior Quality Engineer

      • Provides Quality engineering support in new product development, technical manufacturing sustaining support, equipment/device qualification and process validation • Writes, reviews and approves design verification and validation protocols and reports• Develops process validation requirements (IQ, OQ, PQ) & equipment qualifications• Leads product risk, hazard and functional analyses per IEC-60601 and ISO 14971• Provides technical direction during design transfer activities.• Participates in design reviews and phase gate reviews to provide inputs to validation and verification testing and interpretation of test results• Manages suppliers to improve on their processes including PCB, Vacuum deposition, wire bonding and thick film processes to reduce variation and for process and equipment qualifications • Participates and provides input to training on department/division procedures, and policies.• Performs failure analysis activities (FRACAS) which have typically been escalated from Technical Services, to drive failures to root cause resolution and validate corrective actions are effective. • Conducts reliability margin (i.e. HALT) and reliability growth tests (i.e. RGT) to drive product design changes and improvements on MERZ Ultherapy Ultrasound Skin lifting medical device• Performs Mean Time Between Failures Reliability Analysis on Boards and components to determine if new design meets reliability requirements Show less

    • BD

      Apr 2018 - Aug 2019
      Principal Quality Engineer
    • ICU Medical

      Oct 2019 - Jun 2020
      Senior Quality Engineer
    • Philips

      Jun 2020 - Apr 2023
      Senior Quality Engineer
    • Abiomed

      May 2023 - now
      Senior Quality Engineer

      Senior Quality Systems Remediation Engineer- CAPAs Kaizens

  • Licenses & Certifications

    • IPC-A-610 Specialist

      IPC
      Jan 2013
    • DMAIC Six Sigma Black Belt

      George Group Consulting L P
      Jul 2006
    • Certified Reliability Engineer

      ASQ - World Headquarters
      Mar 2012
      View certificate certificate