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• Diligent R&D manager of medical device testing teams, experienced in leading critical projects, overseeing teams and testing activities• Experienced in automation testing including formation and management of automation testing teams and implementation of automation testing frameworks• Experienced in testing coordination between onshore and offshore teams• Experience with handling multiple projects simultaneously and interacting with different stakeholders• Experienced in total product life cycle and developing and implementing divisional and standard operating procedures and policies
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HiarcMerrimack, New Hampshire, United States -
Sqe ManagerKmc Systems, Inc. Dec 2023 - PresentMerrimack, New Hampshire, Us -
Test ManagerDeka Research & Development Apr 2023 - Aug 2023Manchester, Nh, UsTest manager within the R&D department developing the company’s Hemocare Hemodialysis System Management oversight of system testing including test case and test record review Contributing to 510K submission report -
R&D ManagerAbbott Aug 2021 - Apr 2023Abbott Park, Illinois, UsManager within the R&D department developing the company’s Intravascular Imaging and Physiology Measurement systems, responsible for verification and validation activities including automation and functional software and system testing• Management oversight of user needs validation, system testing, software testing, across multiple product development projects• Formation of software automation testing team along with automation testing framework • Quality process integration of automation testing • Offshore testing coordination • Third party vendor coordination for language translations for international markets • Budgeting and resource estimation to meet organization objectives and milestones for the verification and validation projects• Recruiting, hiring and employee retention• Performance monitoring, talent development and mentoring of the testing teams• Defect management & resolution of field issues• Contribution to total product development life cycle, from requirement, design and risk assessment (FMEA) review, through defect analysis, audit participation• Participation in design control reviews• Contributed to 510K submission inputs • Leadership member of the Abbott association ‘Women Leaders in Action’ for the Westford chapter -
R&D Group LeadAbbott Aug 2018 - Jul 2021Abbott Park, Illinois, UsLead Software Quality engineer within the R&D department developing the company’s Intravascular Imaging and Diagnostics systems• Core Team member of cross-functional development team involved with software design and testing phases of new product development• Supervision and planning of team activities including managing and prioritization of all verification activities and implementation of verification plans• Creation of test plans, strategy and testing scope for each project• Generation of technical reports of test results following defined documentation procedures• Development of standard operating procedures and work instructions to improve test writing and test execution• Responsible for hiring team members -
Sqa Sr. EngineerSt. Jude Medical Oct 2016 - Jul 2018St. Paul, Minnesota, UsSt Jude Medical is now Abbott Medical! Lead member of the SQA department developing the company’s intravascular diagnostics and Imaging system• Core Team member of cross-functional development team involved with design and testing phases of new product development• Supervision and planning of team activities including managing and prioritization of all verification activities and implementation of verification plans• Supervision of team member’s daily and weekly activities • Managing and developing new software requirement specifications• Development and maintenance of testing methods• Implemented a software tool to assist analysis of a key clinical study -
Consulting EngineerMedivision Jun 2014 - Dec 2016Consulting member of a digital pathology startup developing an image based diagnostic platform • Developing and testing of a fluorescence based image analysis algorithm• Creation of an image analysis and reviewing platform for tissue and cell based diagnostics
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V&V Sr. EngineerMedtronic Feb 2016 - Oct 2016Minneapolis, Mn, UsMember of the V&V team working to ensure the company’s Surgical Navigation and Computed Radiography Imaging Systems meet published specifications and are compliant with quality system regulations• Responsible for the design, development, documentation and execution of device verification & validation tests -
R&D Sr. EngineerSt. Jude Medical Oct 2014 - Dec 2015St. Paul, Minnesota, UsMember of the Software Development, SQA and Advanced Technology teams developing the company’s intravascular diagnostics and imaging system• Led efforts to build ‘ground truth’ image-based databases of intravascular plaques, and other clinically relevant features to provide a training and testing framework for automated detection algorithms• Managed and developed software requirement specifications including decomposition of customer requirements and development of system performance specifications in collaboration with Marketing, Regulatory, Design Assurance and R&D departments• Led design verification efforts involving writing test plans and protocols, determination of performance acceptance criteria and test data collection• Supported software development efforts (C++) by managing verification, validation and testing using Matlab-based data analysis tools• Supported the SQA dept. by executing test protocols for software release, performing defect tracking duties including verification of change requests, and risk assessment and hazard analysis (FMEA)• Supported numerous research endeavors by executing projects including image analysis/rendering and proof of concept prototyping from start to completion on time and within budget• Position ended due to company wide layoffs -
Scientific Data AnalystPathogenetix, Inc. Apr 2013 - Apr 2014Member of the Data Analysis team developing an automated system for rapid bacterial strain typing using proprietary Genome Sequence Scanning (GSS™) technology • Performed qualitative analysis of large numbers of sample data to build databases of GSS genome sequences for bacterial strain detection• Successfully automated numerous manual analysis processes by implementation of various macro and Matlab based applications to enhance workflow, reduce human-based errors and user fatigue • Developed test datasets and performed validation studies on in-house software applications• Analyzed source code (Matlab) to identify and correct processing inefficiencies and to improve performance• Supervised day to day operations and activities of microfluidic data acquisition processes, involving SOP creation and training, delegation of workload, maintenance identification and device performance tracking• Position ended due to company closing down -
Biomedical EngineerOn-Q-Ity Oct 2010 - Nov 2012Member of the Imaging & Engineering team developing a proprietary cancer diagnostic and monitoring system based on microfluidics and fluorescence microscopy to enumerate and characterize circulating tumor cells (CTCs)• Developed a proprietary CTC classification system and database• Developed classification guidelines of tumor cell candidate images to increase cell identification accuracy through basic ANOVA and gauge R&R analysis• Assisted in the development and testing of automated computer algorithms to detect rare-cells captured in microfluidic chips to improve the efficiency and quality of the diagnostic system• Developed procedures for testing the detection system including performance, acceptance and rejection criteria• Developed clinical models based on both image and molecular characterization data • Developed Standard Operation Procedures for microfluidic chip imaging and CTC scoring• Trained individuals in tumor cell identification for the purpose of providing clinicians with patient tumor cell loads• Collaborated with various teams within the company including Quality and Manufacturing to improve work flow quality and develop quality control procedures• Assisted in the day-to-day maintenance and calibration of the imaging systems• Assisted in the testing and validation of new scanning protocols and their integration into the production workflow• Provided training and internal tech support of the imaging and detection system to ensure efficient operation• Presentation of data to weekly organizational meetings in pursuit of program milestones• Position ended due to company closing down
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Research AssistantThe Fischbach Laboratory For Therapeutic Tissue Engineering, Cornell University Jun 2010 - Aug 2010Ithaca, Ny, UsMember of the research team with a mission to gain better qualitative and quantitative understanding of the micro-environmental conditions fundamental to the pathogenesis and therapy of cancer• Effectively designed experiments to characterize tissue-engineered constructs to research the effect stem cells have on the mechanical stiffness of their microenvironment during tumor progression • Cultured and differentiated mammalian cells in natural polymer constructs to perform micro-mechanical tests through atomic force and fluorescence confocal microscopy in collaboration with interdepartmental groups -
Farm ManagerR.T. & H. Tims & Sons Jan 2000 - Jan 2005Managed and directed operation of a large pedigree dairy farm in England.• Increased milk production by 150% through implementation of feeding programs and controlled diet• Extended longevity of herd by 40% thereby reducing operating costs through selective breeding of stock and improved husbandry• Hired, trained and supervised staff to perform technical agricultural duties
David Tims Skills
David Tims Education Details
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Cornell University, College Of EngineeringBiomedical Engineering -
New Jersey Institute Of TechnologyBiomedical Engineering
Frequently Asked Questions about David Tims
What company does David Tims work for?
David Tims works for Hiarc
What is David Tims's role at the current company?
David Tims's current role is SQE Manager.
What is David Tims's email address?
David Tims's email address is da****@****ott.com
What schools did David Tims attend?
David Tims attended Cornell University, College Of Engineering, New Jersey Institute Of Technology.
What skills is David Tims known for?
David Tims has skills like Medical Devices, Matlab, Biomedical Engineering, Stem Cells, Data Analysis, Medical Diagnostics, Biomaterials, Molecular Biology, Microscopy, Image Analysis, Imagej, Validation.
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