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Click here or scroll down to respond to this candidateCandidate's Name
Cell (Street Address ) 920-8444 LinkedIn URL: https://LINKEDIN LINK AVAILABLE
EMAIL AVAILABLE White Plains, NY Street Address
EMAIL AVAILABLE
Software Engineer
Quality oriented Software Engineer who resolved Corrective and Preventative Actions (CAPA), developed medical instrument (IVD) software requirements and assays, and supervised and trained colleagues. Certified Scrum Master who wrote and performed verification and validation black box and white box software testing with consideration for User Design 13485, FDA and 21 CFR Part 11 compliance regulations. Expert in Product Development Life Cycle and Software Development Life Cycle (SDLC), Reliability Demonstration Testing (RDT), and Reliability Growth Testing (RGT). Easily deciphers complex technical concepts. Excellent communication, analytical, and organizational skills.
LABORATORY SKILLS
Analyzer Operation: Clinical Chemistry, Immunoassay analyzers, and DNA synthesizers.
Laboratory Information Systems: CentraLink
Laboratory Automation Systems: Labcell and Workcell.
Troubleshooting skills: Mechanical, fluidic, and software.
Material handling: Biohazardous samples and preparation of serum samples, urine samples and chemical solutions. Utilized GMP (GxP) Good manufacturing processes.
COMPUTER SKILLS
Document Databases: Microsoft Test Manager, SAP, DOORS, Teamcenter, and Visual SourceSafe
Error Tracking Databases: Team Foundation Server (TFS), FRACAS (Failure Recording Analysis and Corrective Action System), and DevTrack.
Operating Systems: Windows XP, 2000, NT, 7, and 10.
Applications: Microsoft Excel, Word, Power Point, Project, and Access. SPSS statistics program.
PROFESSIONAL EXPERIENCE
Siemens Healthcare Laboratory Diagnostics Tarrytown, NY April 2012 December 2016
Software Engineer levels 1 and 2
Invited to speak at 20TH Software Design for Medical Devices, for a panel discussion on Incorporating Human Factors & Usability into Marketable Medical Devices to Ensure Product Success. Spoke on Considering FDA and World Usability Regulations in Software Verification Testing.
Provided work reports and input as Verification Representative at Project Management meetings. Reported meeting results to supervisor.
Clarified bug reporting and determined severity levels at Software Change Review Board meetings.
Added 15% new information to Software Requirements documents, test plans, and test design documents authored by co-workers and wrote new feature requirements, test plans, and test designs.
Authored new protocol and performed Sample Tracking and Language Test cases for multiple builds which allowed for release in one year.
Acted as Technical Expert for software installation instruction Test Plans and Test Reports for Product Support involving printers and keyboards and aided in testing.
Tested three builds of Method Deletion Utility software led to release one month early.
Performed multiple software build regression testing for ADVIA 1200 and 1650 for six month release.
Wrote bug fix and new feature test cases for ADVIA 1800 and 2400 Analyzers, supervised and trained one other engineer, and released the software in ten months.
Assisted in testing the Operator s guide and Online help in multiple languages for the Customer Documentation department cut estimated completion time by half.
Released XPT software one month early by performance of Calibration, General Enhancement, UI enhancement, and Regression test cases on multiple software versions.
Candidate's Name PHONE NUMBER AVAILABLE Page2
Reliability Engineer (Contractor) June 2010 March 2012
Recommended by manager for permanent position as Software Engineer based on work results, technical knowledge, and supervision/training of Engineers.
Reported Error causation in (FRACAS) during baseline reliability study on XPT systems aided in the instrument release in one year and six months.
Worked with JEOL Instrument Engineers and Software Engineers on Reagent Inventory errors. Issue was successfully fixed and verification performed.
Accomplished Customer simulation stress testing of the XPT Chemistry systems by utilizing WorkCell, Universal Rack Handler, LineMaster, and Centralink Software for sample delivery, processing and database/ordering led to reliability growth studies..
Effectively performed Centaur XP instruments baseline reliability study which led to Reliability Growth Testing on software, hardware, and component upgraded XPT Centaur Immunology system and release one year and six months later.
Bayer Diagnostics/Siemens Medical Solutions Diagnostics Tarrytown, NY April 2006 October 2009
Software Validation Technician (Contractor)
Exchanged testing methods in Japan for seven weeks. Immediately tested updates as were written by JEOL software programmers led to 50% increase in build release.
Tested interactions of LIS with ADVIA Chemistry Analyzers and provided feedback which led to a 25% increase in test efficiency.
Wrote and performed General and UI enhancement testing, performed Regression testing on multiple software versions, and wrote new protocol and performed Stress Testing on the database which led to release in one year.
Authored and performed new feature calibration testing on ADVIA 1650, 1800, and 2400 Analyzers which led to precise bug reporting, faster developer fixes, and fix verification.
Verified Test Definition software installation and build using comparison software in UNIX and Microsoft OS for Centaur CP, XP, and Classic Immunology Analyzers. All versions tested were released on time.
Bayer Diagnostics Tarrytown, NY June 2004 March 2006
Clinical Chemist (Contractor)
Tested ADVIA 2400 70ml reagent containers for pipet errors due to reagent tray revolution speed which led to testing concentrated reagent packs and subsequent release of 15 new assays.
Developed new contamination set for one test due to saline diluent causing errant values every third sample which began study of all therapeutic drugs assays to determine contamination settings.
Determined Rerun dilutions on ADVIA 1200 Analyzer for over 20 assays transferred from ADVIA 1650 Analyzer.
Extended linearity range of Multi-standard calibration so error rate was within 5% acceptance range
Resolved linearity issue using IMS reagents mixed versus ADVIA reagents which led to release of new version of one blood and urine chemistry assay test.
Studied current Prozone setting and developed new settings for two tests to correct hook effect produced when sample concentration oversaturated reagent concentration.
Performed lot to lot reagent correlation and linearity studies led to release of 25 new blood and urine chemistry assays.
Optimized Parameters of over 20 already released assays on ADVIA 1200, 1650, and 2400 Chemistry Analyzers led to subsequent release.
EDUCATION
SUNY Purchase Majored in biology. Hartwick College Bachelor of Science in Biochemistry.
CERTIFICATIONS
International Scrum Institute: Scrum Master Accredited Certification - Certificate ID 56561799896880 |
