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DTSTART;TZID=America/Chicago:20260311T180000
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DTSTAMP:20260407T020151
CREATED:20260310T024302Z
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UID:11792-1773252000-1773262800@www.mfests.org
SUMMARY:NSBE: Professional Engineer Society Mixer
DESCRIPTION:Overview\n\nConnect with Twin Cities STEM Professionals.  Join engineers\, technologists\, and students from across the Twin Cities for the Professional Engineering Society Mixer\, a collaborative networking event bringing together members from multiple engineering and STEM organizations.\n\n\nParticipating organizations include NSBE\, IEEE\, INCOSE\, SAE\, SHPE\, EWB\, MNSPE\, BIT\, APWA\, SME\, ION\, AIAA\, MN ASQ\, ASCE\, and MFESTS. \nThis event provides an opportunity to connect with professionals\, learn about engineering societies\, and build relationships across disciplines and career stages. Whether you are a student exploring career paths or an experienced professional looking to expand your network\, this evening is designed to bring the engineering community together. \nThe evening will include interactive networking activities\, organization introductions\, and a keynote talk by Steve Gompertz\, QRx Partners\, who will share insights on how engineering plays a critical role in saving and restoring lives through medical technology. \nA catered Italian dinner will be served during the program with both alcoholic and non-alcoholic beverage options. \nStudents\, early-career engineers\, and experienced professionals are all welcome. \n\n\n\nSpeaker\nSteve Gompertz is a leader in Quality Systems management. His career includes roles in quality systems development and implementation\, project management\, engineering automation\, configuration management\, audit\, and software development for companies including St. Jude Medical\, Boston Scientific\, Medtronic\, Vital Images\, and Control Data. He holds a B.S. in Mechanical Engineering from Lehigh University\, and certifications in quality management\, biomedical auditing\, project management\, and configuration management. \nMr. Gompertz has developed a Quality Systems Capability Model merging Risk Management and CMMI concepts to create the only method available to quantitatively measure a quality system’s effectiveness and potential. He is also responsible for coining the term\, “dysfunctional compliance” to describe the situation where a company meets all regulatory and statutory requirements but still experiences significant quality issues due to not addressing quality from a true systems perspective. \nSteve Gompertz’s LinkedIn profile \n\n\n\n\nVenue Information: Walter Library | University of Minnesota Libraries – Room 402 \nParking Information: https://campusmaps.umn.edu/walter-library
URL:https://www.mfests.org/event/nsbe-professional-engineer-society-mixer/
LOCATION:Walter Library East Bank – University of Minnesota\, 117 Pleasant Street Southeast\, Minneapolis\, Minnesota\, 55455
CATEGORIES:NSBE
ORGANIZER;CN="NSBE":MAILTO:publicrelations@nsbetcpc.org
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DTSTART;TZID=America/Chicago:20260317T163000
DTEND;TZID=America/Chicago:20260317T200000
DTSTAMP:20260407T020151
CREATED:20260310T022308Z
LAST-MODIFIED:20260310T022308Z
UID:11783-1773765000-1773777600@www.mfests.org
SUMMARY:INCOSE: Forgotten Star + INTERTEK Facility Tour
DESCRIPTION:Forgotten Star + INTERTEK FACILITY TOUR\n\n\n\n\n\n\n\n\n \n\n\n\n\n\n\n\nBy: North Star Chapter INCOSE\n\nFollow\n\n\n\nForgotten Star Brewing Co.Fridley\, MN \nTuesday\, Mar 17 from 4:30 pm to 8 pm\n\n\n\nOverview\n\n\n\n\n1. Nothing via Mailchimp is authorized by the INCOSE North Star Chapter. • 2. Gather at Forgotten Star Brewing • 3. Intertek facility tour \n\n\n\n\n• Please avoid clicking links in Mailchimp email that claims to be from the INCOSE North Star Chapter\, and disregard any such email. The Chapter discontinued use of Mailchimp after January. A security notice follows the event announcement below. \n• Please come and join us in-person for the March INCOSE North Star event\,\nfalling incidentally on St. Patrick’s Day\, progressing from Forgotten Star Brewery to a facility tour of Intertek. \nRSVP: at right\, red “Reserve a spot” button \nlocation: two sites in Fridley\, Minnesota 55421 \nAgenda \nsite: Forgotten Star Brewing Company\n38 Northern Stacks Drive \n4:30 – Networking and socializing—Ask the staff and look for signage\, for direction to the space set aside for the INCOSE North Star Chapter. \n5:30 – Welcoming remarks from the North Star Chapter\, outside Forgotten Star’s doors\, weather permitting \nProgress north to the northeast corner of Intertek\, in the Northern Stacks industrial park —option: 20 minutes’ walk up the tracks. \nsite: Intertek\n40 51st Way NE #100 \n6:00 – Reconvene in the lobby in the northeast corner. \nIntertek is a Total Quality Assurance resource for operations and supply chains in multiple industries. 1000 laboratories and offices in more than 100 countries provide outsourced\, innovative\, tailored\, mission-critical assurance\, testing\, inspection and certification solutions. The Fridley location is the home of the region’s Electrical Safety testing teams; including Medical Device\, General Industrial and EMC/EMI. \nWith the same street address\, Intertek Building and Construction (Professional Service Industries) provides assurance\, testing and inspection in civil and commercial construction. This includes construction materials testing\, geotechnical services\, environmental consulting\, industrial hygiene\, and specialty testing \nSpeakers\, conducting the tour for us \nMary Margaret Bartik\, PhD [linkedin.com]\, Medical Device Electrical Safety Team Lead Centered in Microbiology & Immunology\, with a substantial background in academia\, business\, and work in the industry; Biotechnology\, Medical Devices\, Cell Culture\, R&D\, and business development. \nBefore 2023\, Mary Margaret owned MMB Scitech Consulting and Midwest SiTech\, as a consultant for scientific writing\, editing and grantsmanship\, proposal development\, data analysis and experimental design\, Business development\, strategic planning\, and laboratory design. \nByron Smith is the Engineering Manager for Electrical Safety at Intertek (Fridley\, MN) where he has been helping clients achieve their testing and certification goals for the past 11 years.He started as an engineer testing medical devices to national and international standards before moving to management roles within the organization. He now leads the lab with an emphasis on improving training\, doing work the right way\, being open-minded when problem solving\, and clearly communicating with clients. \nByron graduated from Iowa State University with a degree in Aerospace Engineering. Outside of work he enjoys competing in triathlons\, hiking\, and playing overly complicated board games with his friends. \nAgain\, please \n\nDisregard anything from Mailchimp claiming to represent the INCOSE North Star Chapter.\nLet us know how many are coming with the red button at upper right\, “Reserve a spot”\nGather between 4:30 and 5:30 at Forgotten Star.\nMeet at 6:00 in the lobby at the northeast of Intertek.\n\n____ \nSecurity Notice: unauthorized email \nThe Mailchimp deliveries Feb. 11 with the subject “information” were not authorized by the North Star Chapter. No notices distributed by Mailchimp after January have been authorized by the North Star Chapter. \nAt this time\, the chapter has no indication that financial or sensitive personal information was exposed. However\, email addresses in our contact list may have been accessed. We are issuing this notice out of an abundance of caution for our members and community. \nAt this time\, official chapter communications are distributed through our chapter Gmail account\, Eventbrite\, our website\, and the Connect platform internal to INCOSE members. \nNot necessarily related or associated with the North Star Chapter\, email this month regarding continuing education\, from “Huntress” re assigned tasks\, are also considered illegitimate and so a risk for phishing and malicious links.
URL:https://www.mfests.org/event/incose-forgotten-star-intertek-facility-tour/
LOCATION:Forgotten Star Brewing Company\, 38 Northern Stacks Drive\, Fridley\, Minnesota\, 55421
CATEGORIES:INCOSE
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DTSTART;TZID=America/Chicago:20260318T173000
DTEND;TZID=America/Chicago:20260318T191500
DTSTAMP:20260407T020151
CREATED:20260310T143009Z
LAST-MODIFIED:20260310T143242Z
UID:11794-1773855000-1773861300@www.mfests.org
SUMMARY:ASQ: Biomedical Consortium - Situational Leadership
DESCRIPTION:Situational Leadership – \nInfluence people to build solutions\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nYou didn’t get into quality to be the bottleneck. \nYou’re here to build excellence and ensure quality. But if your days are filled with friction\, constantly having to enforce rules with resistant colleagues and frustrated teams\, it’s exhausting. Being seen as the primary rule enforcer can make you feel like a bottleneck\, not a strategic partner. \nIt’s time for a new approach. \nIn this 90-minute virtual masterclass\, you will learn a proven leadership framework to diagnose why people resist and exactly how to adapt your approach to get buy-in\, reduce conflict\, and champion quality effectively. \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nClick Here for more info or to register!
URL:https://www.mfests.org/event/asq-biomedical-consortium-virtual-session/
LOCATION:Webinar
CATEGORIES:ASQ
ORGANIZER;CN="ASQ-MN%20Section":MAILTO:info@mnasq.org
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DTSTART;TZID=America/Chicago:20260414T180000
DTEND;TZID=America/Chicago:20260414T200000
DTSTAMP:20260407T020151
CREATED:20260310T022727Z
LAST-MODIFIED:20260310T022727Z
UID:11786-1776189600-1776196800@www.mfests.org
SUMMARY:INCOSE: Integrating AI into Systems Engineering for Medical Devices: A Case Study
DESCRIPTION:Overview\n\n\n\n\nFindings from Boston Scientific’s early practice with IntelliU’s ALEX implementation \n\n\n\n\nAgenda (Central Standard Time) \n6:00 – Network and socialize over pizza (provided) \n6:30 – Welcome & INCOSE Chapter Overview by Chapter President \n6:45 – Presentation\, Integrating AI into Systems Engineering for Medical Devices: A Case Study from Practice \n7:45 – Adjourn \nHybrid Microsoft Teams meeting \nMeeting ID: 290 561 832 063 94 Passcode: qJ7dC6L5 \nJoin: teams.microsoft.com/meet/29056183206394?p=cGnz114ed5Cej4fUFn \nSynopsis \nFollowing development discussed at an earlier presentation to the chapter\, of IntelluU’s ALEX platform\, Boston Scientific is exploring the future of medical device design through its stategic evaluation of AI capabilities. The engineering team is leveraging ALEX to augment and accelerate quality design while navigating the organizational and technical realities of AI adoption. \nThis presentation shares the methodology\, challenges\,and measurable impacts from deploying ALEX within Boston Scientific’s engineering workflows\, demonstrating how AI not only boosts productivity but also elevates design quality. Attendees will gain actionable insights into the future of AI in medtech\, including best practices for implementation and scaling AI-driven engineering. \nPresenters’ Biographies \nAaron Bowser is an experienced R&D leader with a background in systems engineering\, process development\, and technical team leadership. As Senior R&D Manager of Systems Engineering at Boston Scientific\, he leads teams developing implantable medical devices\, focusing on collabotration\, problem-solving\, and helping engineers grow in their careers. Aaron has been involved in integrating AI-driven tools into engineering workflows\, including efforts to improve requirements analysis and test scenario generation. He is particularly interested in how AI can enhance efficiency\, streamline development processes\, and support engineers in tackling complex challenges. With experience spanning both medtech and semiconductor industries\, Aaron has held engineering and leadership roles at Boston Scientific\, Seagate Technology\, and Cypress Semiconductor. He has guided teams through complex product development efforts\, balancing innovation with the realities of working in highly reglulated environments. Aaron holds a Bachelor of Science in Electrical Engineering from the University of Minnesota – Twin Cities. He enjoys working at the intersection of technology and teamwork\, applying new tools and approaches that help engineers do their best work. \nXiaofan Mai is a visionary leader\, fueled by growth and innovation. Her passion lies in developing digital techologies that advance patient care through customer-driven strategies and focused execution. \nAs the CEO and Founder of IntelliU LLC\, Xiaofan brings over 20 years of experience to the table. She has successuflly launched numerous new products and innovative technologies for Fortune 500 companies\, leading cross-functional teams across the globe. Her expertise spans strategy\, new product development\, and collaborative partnerships to drive business growth in regulated markets. Having spent two decades in the field before venturing into entrepreneurship\, she possesses a passionate vision of AI and a deep understanding of the industry. IntelliU addresses critical gaps in healthcare\, aiming to reduce risk to patients while expediting business commercialization and growth for its clients. \nXiaofan holds an MBA from the Carlson School of Management and an MA from the Education Department\, both from the University of Minnesota. She enjoys the beautiful four seasons\, rich culture\, and vibrant performing arts scene that Minnesota offers. As an international student from Beijing\, China\, who arrived 29 years ago\, she appreciates the diversity and “Minnesota Nice” culture that have allowed her to thrive. She considers Minnesota her second hometown.
URL:https://www.mfests.org/event/incose-integrating-ai-into-systems-engineering-for-medical-devices-a-case-study/
LOCATION:Augsburg Park Library\, 7100 Nicollet Avenue\, Richfield\, Minnesota\, 55423
CATEGORIES:INCOSE
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BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20260414T183000
DTEND;TZID=America/Chicago:20260414T200000
DTSTAMP:20260407T020151
CREATED:20260310T143213Z
LAST-MODIFIED:20260310T143213Z
UID:11796-1776191400-1776196800@www.mfests.org
SUMMARY:ASQ: Program Meeting - First Pass Design Controls
DESCRIPTION:First Pass Design Controls –\nGetting it Right on your First Medical Device\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nIf you’re part of a new startup or an insulated development team in a larger company\, you probably know how daunting it can be to collect the evidence required to demonstrate to a regulatory body that design requirements have been met. \nFDA regulations require design controls to help ensure this\, which can translate into many hours of reviews\, oversized spreadsheets\, and enough signatures to slow a change assessment system to a crawl. \nBut when implemented correctly\, design controls enhance – rather than hinder – development efforts while providing the assurance needed to enter the submission process with confidence. \nThis presentation takes a practical look at design controls within FDA regulations and how they’ve been implemented across the medical device industry. And you’ll earn 0.2 RU’s (Recertification Units)! \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nClick Here for more info or to register!
URL:https://www.mfests.org/event/asq-program-meeting-first-pass-design-controls/
LOCATION:Webinar
CATEGORIES:ASQ
ORGANIZER;CN="ASQ-MN%20Section":MAILTO:info@mnasq.org
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