David Lewinski Email and Phone Number
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Engineering leader with over 30 years of experience in leading new product development programs and driving operational excellence. Experience in both establishing departmental structures for success and in leading project teams to deliver products to market. Expertise in establishing processes, integrating development tools, and building collaborative teams. Extensive experience in stage-gate development cycles and reporting out to executive leadership team. Ability to manage multi-site teams including offshore teams. Proven leader of both software teams and cross-functional teams in the development and launch of multiple devices, consumables, and software systems. Expertise in requirements management, risk management, project management, design process, and design verification and validation. Change leader able to work collaboratively to improve development and project management processes, identify and install productivity tools, and establish metrics for tracking progress and quality. Reputation for setting high expectations within team and developing others.Specialties: Creating and establishing highly motivated teams dedicated to high quality to meet customer needsOptimizing organizational structures for high performanceIdentifying key metrics to drive project team and organizational behaviorsMedical device developmentProgram managementPhase gate development processDesign ControlSoftware developmentEmbedded systemsSystem ValidationOrganizational Leadership
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PrincipalIronwood Medtech SoftwareFlorida, United States
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Vice President, Software, Controls And AutomationSteris Jun 2023 - Oct 2024Mentor, Oh, UsOversee diverse, multi-site organization developing embedded software applications, controls, connectivity and automation solutions for healthcare capital equipment. Established culture of continuous improvement for higher quality products, predictive project execution, and more secured solutions. -
Senior Director, Controls EngineeringSteris Jan 2020 - Jul 2023Mentor, Oh, UsLead team of software and electrical engineers in developing and maintaining electronic control systems, software applications, and connectivity solutions for class II medical devices. Utilize my extensive experience to develop and guide high performing teams to deliver safe, effective, high quality products. My teams have shown consistent improvement in both quality and on time performance by continuing to monitor ourselves and employing best practices and process improvements to meet increasingly higher standards.
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Engineering Director, Software And Control SystemsSteris Jul 2015 - Dec 2019Mentor, Oh, UsLead team of software and electrical engineers in developing and maintaining control systems and software applications for sterilizers for healthcare industry.
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Director, Program Management, Core Team LeaderMedtronic Minimed Apr 2014 - May 2015Minneapolis, Mn, UsCross-functional leader of new product development program for insulin pump business. Led team in preparations for design validation, clinical studies, user evaluations, and launch preparations for MiniMed 640G insulin pump. Formed and lead team in driving operational excellence by seeking and implementing product cost improvements and improving reliability via design, process, and supply train changes for new pump platform. -
Director, Software EngineeringMedtronic Minimed Feb 2009 - Apr 2014Minneapolis, Mn, UsResponsible for the software development process, staffing, and leadership. Implemented best practices in software activities including requirements management, design, unit testing, and configuration/release management. Implemented ALM and automation tools to establish processes and better manage activities. Sourced three separate software programs from onsite and offshore teams. Initiated data driven planning and decision making via collection of relevant metrics.
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Director Of R&DSmiths Medical Dec 2004 - Oct 2008San Clemente, California, UsLed multi-discipline R&D group in the development of Class II critical care medical devices. Responsible for new product development of both capital equipment and disposables. Managed a group of 50+ consisting of employees, contractors, and outsourced resources. Created and kept budgets of $6MM+. Established and enforced design controls and validation processes. Successfully launched new respiratory products and upgraded best in class infusion pump. -
Software Engineering ManagerSpectrx Feb 1995 - Dec 2004UsLed software and multi-discipline project teams in the development of non-invasive medical devices including a diabetes screening instrument, bilirubin meter, and cervical cancer detection device. All of these devices utilized photonics to detect disease or medical condition.Established processes in accordance to FDA regulations and ISO standards. -
Senior Software EngineerAlcott Chromatography May 1993 - Feb 1995Designed and developed embedded software for auto-samplers supporting high pressure liquid chromatography.
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EngineerSiemens Energy & Automation Apr 1989 - Feb 1993Munich, DeDesigned microcontroller-based printed circuit boards for motor drives.
David Lewinski Skills
David Lewinski Education Details
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Georgia Institute Of TechnologyElectrical Engineering
Frequently Asked Questions about David Lewinski
What company does David Lewinski work for?
David Lewinski works for Ironwood Medtech Software
What is David Lewinski's role at the current company?
David Lewinski's current role is Principal.
What is David Lewinski's email address?
David Lewinski's email address is da****@****cal.com
What is David Lewinski's direct phone number?
David Lewinski's direct phone number is (800) 548*****
What schools did David Lewinski attend?
David Lewinski attended Georgia Institute Of Technology.
What are some of David Lewinski's interests?
David Lewinski has interest in Embedded Systems, Economics, Devops, Medical Devices, Lean For Software, Cultures, Dfss, Values Based Companies.
What skills is David Lewinski known for?
David Lewinski has skills like Medical Devices, Cross Functional Team Leadership, Product Development, R&d, Design Control, Fda, Testing, Project Management, Embedded Systems, Embedded Software, Management, Process Improvement.
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