My experience includes the full range of the manufacturing process, from assembly to customer support, including all aspects of design, from customer requirements to EM design to production and product development quality. This perspective gives me the ability to work effectively with people all along the product's cycle, and to understand what is required for a complete product.My FOCUS is on medical device quality, especially Risk Management and Cybersecurity processes. I have created and maintained processes that are both compliant and effective.Training and team-building are passions for me. I have taught a variety of subjects in a variety of settings, from the corporate setting to a leading university to a roadside in Belize. I build teams with an eye for passion and practicality, knowing that the best people are the ones who will care the most about the goals.I believe the most important role of a leader is to promote those being led, so they can reach their potential and fulfill the goals of them and their employer. Specialties: Cybersecurity process to 81001-5-1 and other standardsMedical device risk management to 14971EMC training and experiencePCB design experience (Protel, Mentor Graphics)Mechanical design (AutoCAD)Contact me at SafeAndSecureMD@Gmail.com to discuss how I can support your project!
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Principal ConsultantHansen EnterprisesDexter, Mi, Us -
Principal ConsultantHansen Enterprises Llc Jul 2024 - PresentMichigan, United StatesConsulting for medical device risk management and cybersecurity; process compliance, training, and kickstarting
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Academic Support For Bme ProgramsVarious Universities 2013 - PresentSe MichiganGuest-lecturer for the Biomedical Engineering programs at two Universities (U of M, LTU), supporting projects classes in the undergrad and graduate levels; topics include Risk Management, Quality and Design Controls.Serving on the Industrial Advisory Board for two Universities (LTU, Wayne State), advising on best practices for the programs to improve the effectiveness of the education and helping graduates realize immediate benefits in the industry.These activities have been… Show more Guest-lecturer for the Biomedical Engineering programs at two Universities (U of M, LTU), supporting projects classes in the undergrad and graduate levels; topics include Risk Management, Quality and Design Controls.Serving on the Industrial Advisory Board for two Universities (LTU, Wayne State), advising on best practices for the programs to improve the effectiveness of the education and helping graduates realize immediate benefits in the industry.These activities have been promoted and supported by my employer, Terumo CVS / Terumo Heart. Show less
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Principal Engineer, Quality And RiskTerumo Heart, Inc. Sep 2016 - Jul 2024Ann Arbor, MiRisk-wrangler for a next-generation vascular imaging device.Acting Risk Manager for the project, including oversight of all risk activities; interfacing with Medical Experts covering three global regions (US, EU and Japan); maintaining the overall Risk Management process.Serving on the Terumo global Best Practices committee to standardize Quality practices across all sites.Diving into the Cybersecurity realm to create a process for the device over its total life… Show more Risk-wrangler for a next-generation vascular imaging device.Acting Risk Manager for the project, including oversight of all risk activities; interfacing with Medical Experts covering three global regions (US, EU and Japan); maintaining the overall Risk Management process.Serving on the Terumo global Best Practices committee to standardize Quality practices across all sites.Diving into the Cybersecurity realm to create a process for the device over its total life cycle. Show less -
Pdqe Chief / Dqa Sr. SupervisorTerumo Cardiovascular Systems 2004 - Sep 2016Hired, trained and supervised engineers working on product development and redesignServed as Quality role in product development core team working on blood parameter monitoring instrumentAssessed and revised company Risk Management procedures; improved alignment with ISO 14971Supported implementation of IEC 60601-1 Third EditionProvided Quality oversight of design changes to existing products -
Sr Engineer - QualityTerumo Cvs Jan 2004 - Nov 2009Product Development Quality Engineering (May 2007-November 2009): Validation of new and major revision products and their processes.Manufacturing Quality (January 2004-May 2007): Handling production quality issues within the framework of the Quality system. -
Sr. Design EngineerApplied Dynamics International 1995 - 2003Design and development engineer: Designed support and interface hardware for simulation systems, including power, signal conditioning, enclosure, environmental monitoring and custom requirements.Led a project to create a matrix switching system for an aerospace simulation application.Designed analog signal conditioning and simulation circuitry, including PCB layout. -
EngineerApplied Dynamics International 1995 - 2003Supported design projects including enclosures, power systems, and PCB designPerformed EMC testing, both preliminary and at a test lab, including safety, ESD, and EFI to 101-x and CISPR 11Supported design of analog and digital circuitry used for signal simulation and interfacing
William Hansen Education Details
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Electronics -
Digital Electronics
Frequently Asked Questions about William Hansen
What company does William Hansen work for?
William Hansen works for Hansen Enterprises
What is William Hansen's role at the current company?
William Hansen's current role is Principal Consultant.
What schools did William Hansen attend?
William Hansen attended Wayne State University, Washtenaw Community College.
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William Hansen
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