ASQ: Biomedical Consortium - Situational Leadership
2026-03-18 17:30 - 19:15 (America/Chicago) | Webinar
Situational Leadership –
Influence people to build solutions

You didn’t get into quality to be the bottleneck.
You’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.
It’s time for a new approach.
In 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.

Click Here for more info or to register!

SAE: Regional Collegiate Vehicle Showcase
2026-04-11 09:00 - 12:00 | AutoMotorPlex Medina, 3600 Arrowhead Drive, Medina, MN, 55340, United States
The Twin Cities Section of SAE will be hosting a regional collegiate design vehicle showcase at the AutoMotorPlex-Medina ‘Caffeine & Octane’ Event on April 11th. Local collegiate teams be showing their vehicles at the event. This is a great opportunity to meet the students and see the great work they have done on their vehicles.
Events — Automotorplex

INCOSE: Integrating AI into Systems Engineering for Medical Devices: A Case Study
2026-04-14 18:00 - 20:00 | Augsburg Park Library, 7100 Nicollet Avenue, Richfield, Minnesota, 55423
Overview

Findings from Boston Scientific’s early practice with IntelliU’s ALEX implementation

Agenda (Central Standard Time)
6:00 – Network and socialize over pizza (provided)
6:30 – Welcome & INCOSE Chapter Overview by Chapter President
6:45 – Presentation, Integrating AI into Systems Engineering for Medical Devices: A Case Study from Practice
7:45 – Adjourn
Hybrid Microsoft Teams meeting
Meeting ID: 290 561 832 063 94 Passcode: [REDACTED]
Join: teams.microsoft.com/meet/29056183206394?p=cGnz114ed5Cej4fUFn
Synopsis
Following 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.
This 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.
Presenters’ Biographies
Aaron 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.
Xiaofan 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.
As 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.
Xiaofan 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.

ASQ: Program Meeting - First Pass Design Controls
2026-04-14 18:30 - 20:00 | Webinar
First Pass Design Controls –
Getting it Right on your First Medical Device

If 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.
FDA 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.
But when implemented correctly, design controls enhance – rather than hinder – development efforts while providing the assurance needed to enter the submission process with confidence.
This 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)!

Click Here for more info or to register!

MFESTS: Q2 Planning Meeting
2026-04-16 18:00 - 19:30 | Join Zoom Meeting
Please be prepared to discuss some key action items we can discuss again with the whole group at the MFESTS Q2 mtg on Tuesday 4/28 at the Ridgedale Public Library (Minnetonka) 6-7:30p. I intend that at the Q2 mtg we will pick 2-3 action items that seem most urgent/beneficial to get started on and get some people to volunteer to help get them accomplished before the Q3 mtg in July. Some key things we’ve talked about at our past mtgs include:

Dan has put together a master list of engineering/scientific societies and contact info. He also has started working with AirTable to help facilitate communications w/ these societies in the near future.

Venkat has shared some basic principles we could follow to develop a mentoring program that would begin w/ MFESTS representatives reaching out to their respective societies for any potential volunteers who would be willing to mentor as needed.

Roquesan and Jason have both given several ideas of how we can and really should reach out to engineering/science students at our local universities/colleges and build connections–with special focus to them as they start their new academic year this fall.

I’m hoping to use Dan’s contact info in the near future to try to reach out to a few societies that may know nothing about MFESTS but start initial conversations with them about us and ask what they might want in our kind of “umbrella” organization.

As well as several other good ideas we can look into (ex. finding information about grants/funds that might be available for society events or helping students w/ research projects/etc.)

Even if you can’t attend this Thursday’s planning mtg, please try to attend the MFESTS Q2 mtg 6-7:30p on Tuesday, April 28th either in-person at the Ridgedale Public Library (Rm 172) or online in the Zoom call. Thank you. If you can’t attend, then please email your thoughts and questions about a few simple actions we can take to try to provide real, meaningful value to our current member societies. We left the January Q1 mtg with the understanding that, as good as it is that we have a new president, that our continued existence as an “umbrella society” is completely dependent on how successful we can be at providing meaningful value to others.

MnSPE: Young Engineer's Network Happy Hour
2026-04-21 16:00 - 19:00 | Steel Toe Brewing, 4848 W 35th St, St Louis Park, Minnesota, 55416
MnSPE Young Engineer’s Network Happy Hour Event at 4pm on April 21 at Steel Toe Brewing in St. Louis Park. It’s mainly for participants in MnSPE’s Young Leadership training series, but anyone can attend. No registration required.

INCOSE: Systems Engineering in Healthcare Conference
2026-04-28 - 2026-04-30 | Event location to be provided upon registration
The Healthcare Working Group invites you to participate in the 11th Annual INCOSE Healthcare Systems Conference (2026) in Bloomington, Minnesota. The INCOSE Conference on Systems Engineering in Healthcare enables participants to share the best practices in the latest Systems Engineering topics as applied to Healthcare. The conference theme is “Advancing the Practice of Systems Engineering in the Healthcare Industry.”

MFESTS: Q2 Board Meeting
2026-04-28 18:00 - 19:30 | Ridgedale Library, 12601 Ridgedale Dr., Minnetonka, MN, 55305, United States
I intend that at the Q2 mtg we will pick 2-3 action items that seem most urgent/beneficial to get started on and get some people to volunteer to help get them accomplished before the Q3 mtg in July. Some key things we’ve talked about at our past mtgs include:

Dan has put together a master list of engineering/scientific societies and contact info. He also has started working with AirTable to help facilitate communications w/ these societies in the near future.

Venkat has shared some basic principles we could follow to develop a mentoring program that would begin w/ MFESTS representatives reaching out to their respective societies for any potential volunteers who would be willing to mentor as needed.

Roquesan and Jason have both given several ideas of how we can and really should reach out to engineering/science students at our local universities/colleges and build connections–with special focus to them as they start their new academic year this fall.

I’m hoping to use Dan’s contact info in the near future to try to reach out to a few societies that may know nothing about MFESTS but start initial conversations with them about us and ask what they might want in our kind of “umbrella” organization.

As well as several other good ideas we can look into (ex. finding information about grants/funds that might be available for society events or helping students w/ research projects/etc.)

MnSPE: Annual Meeting and Awards Ceremony
2026-05-01 08:00 - 17:30 | North Oaks Golf Club, 54 E Oaks Rd, North Oaks, Minnesota, 55127
MnSPE’s Annual Meeting and Awards Ceremony on May 1, 2026 at North Oaks Golf Club. The event includes lunch and educational sessions worth 4 PDHs. Registration is required. Cost is $105 for MnSPE members and $260 for non-members.

INCOSE: Chapter Planning Meeting
2026-05-05 18:00 - 19:00 | Normandale Community College, Parnership Center, 9547 College View Road, Bloomington, Minnesota, 55431
May 5, 6pm INCOSE chapter planning meeting, Normandale CC, 2d fl of Partnership Center, Room P1844, essentially 9547 Collegeview Rd, Bloomington 55431-4309—Anyone is welcome.

INCOSE: Overview of Project Wildfire
2026-05-19 18:00 - 19:00 | Normandale Community College, Parnership Center, 9547 College View Road, Bloomington, Minnesota, 55431
May 19, 6pm overview of INCOSE Project Wildfire, a multidisciplinary analysis of the response to the 2020 Holiday Farm Fire that burned 173,393 acres in Oregon
in either Normandale P1840 or the White Bear Lake Library Community Planning Room

ASQ: To Accelerate AI, Focus on Quality
2026-05-21 17:00 - 18:00 | Virtual Webinar – Webex / Microsoft Teams / Zoom
About this event
As industry changed over the past 150 years, how we think about and practice quality has changed:

In the Inspection era, we asked “Is this good enough?”
In the Design era, we asked “How do we build this right the first time?”
In the Engagement era, we asked “Is everyone aligned on what good means?”

But now, we’ve entered the AI era, where generative tools make creating code and artifacts almost free. This means the ability to differentiate based on quality becomes the scarce resource. In the AI era, we need to ask “Given a thousand possible solutions, which one is right for us?” This indicates that value is migrating from how we produce to how we define and judge the quality of what we produce. We built machines to create, only to discover the harder problem was knowing what we wanted. What now?
AI can now generate a thousand solutions in the time it took you to build one. So why isn’t everyone 1,000x more productive?” The companies winning with AI aren’t the ones generating the most code the fastest. They’re the ones who know what “good” looks like.
As production becomes effortless, defining quality becomes everything.
Venue: Zoom/Live Online Event. Zoom Link will be provided closer to the event date.
Date: Thursday, May 21, 2026
Time: 5:00 pm – 6:00 pm CST
Cost: $15
You do not have to be an ASQ Member to attend. We would love to have you join the conversation.
THE EMAIL USED DURING REGISTRATION IS THE EMAIL USED FOR ALL EVENT COMMUNICATION, INCLUDING THE ZOOM LINK.
Certificates of Completion: Issued via email, after event completion, for .2 ASQ RUs or .2 CEUs
Questions: Please contact Karen Peifer, Committee Chair, at asqmnbmc@gmail.com
Your Speaker
Nicole Radziwill
Dr. Nicole Radziwill is Co-Founder and CTAIO of team-x.ai, focused on unlocking human+AI potential one team at a time. A former SVP and Chief Data Scientist and tenured Associate Professor of Data Science and Production Systems, Nicole is an Academician in the International Academy of Quality (IAQ) a Fellow of the American Society for Quality (ASQ). She has a PhD in Quality Systems, and is the author of data science and statistics textbooks used in 30+ universities, as well as Connected, Intelligent, Automated: The Definitive Guide to Digital Transformation and Quality 4.0 (ASQ Quality Press, 2020) and Data, Strategy, Culture & Power (2024).
Sponsor Information
The MN ASQ Biomedical Consortium (BMC) is a group of quality professionals promoting and advancing quality tools, principles, and practices through educational events. We focus on the medical device industry but promote events for other regulated environments.

Follow us on LinkedIn to stay informed of upcoming events: https://www.linkedin.com/showcase/90642322/

To become a member of the MN ASQ Biomedical Consortium, please contact Karen Peifer, Committee Chair or Sahi Datla, Committee Co-Chair, at asqmnbmc@gmail.com.
The American Society for Quality (ASQ), is a knowledge-based global community of quality professionals, with nearly 80,000 members dedicated to promoting and advancing quality tools, principles, and practices in their workplaces and communities. As your career partner, ASQ membership benefits are designed to help meet your growing needs as a quality professional. Membership provides exclusive access to quality knowledge, solutions, and resources to solve challenges, and skill development to advance your career. ASQ is committed to providing enhanced expertise, professional networks, tools, and solutions to help our members advance their products, services, and industries.
ASQ: https://www.asq.org/
