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Technology Leader passionate in guiding medical device development projects through the system integration and design verification phases so they finish well. Has proven success in creating highly productive development teams. Demonstrated ability to recruit talent, create and execute strategic plans and to manage a multimillion-dollar budget. Excellent people skills, superb communicator, and polished speaker. Diverse experience spans multiple industries including medical device, energy conservation, telemetry, space electronics, test & instrumentation, and satellite command & control.Strengths and Experience:Product Development Process • Project Management • Risk Management • FMECA/FMEA • Requirements Development/Review • System, Hardware, and Software Design • Design/Technical Review • Test Design, Verification, and Validation • Design Verification Tool Design/Qualification • Regression Analysis • Product Development Process Audit/Report • 62304 Process Compliance • Issue Management • Process Development • Operational Risk Management • QMS/SOPs • CE Mark, FDA, and ISO 13485 Compliance • Corporate Policy/Procedure Development • International/Domestic Sales & Marketing Support • Team Building in Diverse Workforce • Leadership of Cross-Functional Project Teams • Polished Presentation SkillsContact email: kimwindingland@gmail.com
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Development Qa Director, Development Qa Program Manager, Development Qa ManagerMinnetronix, Inc. Mar 2011 - Feb 2019Greater Minneapolis-St. Paul AreaManage $15-20M/year medical device development operation as part of a team of functional managers • Significantly improved the overall performance of the group by 1) setting clear, consistent objectives and expectations, 2) establishing systematic planning habits, 3) improving internal and external communication, and 4) recruiting high performance team members • Increased labor margin by 26% that translated to $626K increase in profit during the first 12-month period after implementing a new recruiting program • Developed Design Verification Estimator that was accurate within 10% • Launched Design Verification metrics that provided predictable requirement-based design verification -
Test Engineer ContractorMinnetronix, Inc. Jun 2010 - Mar 2011Greater Minneapolis-St. Paul AreaLed 17-person design verification team for the controller of a class 3 Left-Ventricle Assist device to support PMA submittal.
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Business OwnerEnergy Cost Cutters Oct 2008 - Dec 2011Reduce energy cost 30-70% for our customers while improving their operating environment with typical payback of less than three years. -
Business OwnerAlloy Technologies Jun 2007 - Mar 2010As an independent reseller of enterprise computing, network and storage technologies, we provided solutions to our customers at a fraction of the cost of traditional sales channels. -
Engineering Manager, Senior Project Engineer, Senior Qa Software EngineerNonin Medical, Inc. 1998 - 2006Led 35-person engineering department doing technology development, product development and continuation engineering • Directed operational planning and execution of $7M budget • Released eleven new medical devices of which four were first to market and completed 37 significant product updates • Reduced development time for new products by 60% • Led development of medical devices from initial concept through product launch • Created software verification and validation process ensured compliance to FDA, CE Mark, and ISO 13485 standards • Established and led the Software Quality Assurance Group that contributed to the company’s rapid growth -
Electronics ManagerNordictrack 1997 - 1998Responsible for redefining electronics strategy, product development and Asian vendor relationships. Initiated development for innovative fitness computer-unprecedented in market. -
Electronics Group Leader, Engineering Liaison, Senior Project Engineer, Electrical EngineerLoral Instrumentation 1984 - 1997I held a variety of titles including Senior Project Engineer, Front-End Electronics Group Leader, and Engineering Liaison. I served multiple roles during tenure including product development and project management for non-recurring engineering (NRE). I supported sales and marketing to create solutions to customer needs and identify new markets. Successfully launched the first Windows-based Telemetry Ground System and industry’s first all-in-one series of high-performance digital bit synchronizers.
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Electrical Design EngineerGeneral Dynamics 1982 - 1984One of two engineers to design the Control Unit for the Shuttle Centaur. Also, designed the production automated test system for the Control Unit.
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Kim Windingland has skills like Cross Functional Team Leadership, Testing, Quality Assurance, Product Development, Leadership, Program Management, Project Management, Medical Devices, Strategic Planning, Process Improvement, Product Management, Engineering.
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