S1E21 Weird Al, Strong Creative-Analytical Linking, & Bomb Squads | Margaret Koga Ward

Being an Engineer · 17 Jul 2020 · 48m · Episode 21

What this episode covers

Margaret Koga Ward, founder of Terafram, discusses her career in automotive and medical device engineering, highlighting her work on mobile X-ray systems for bomb squads and femoral head implants. She explains how she solved a root cause failure involving dimensional instability in orthopedic trials by identifying thermal expansion issues during sterilization cycles. Ward also shares insights on being a woman in engineering, the importance of creative-analytical linking, and her current role as a quality auditor and trainer for ISO 13485 compliance.

Mentioned

Companies
Pipeline Design & Engineering, Terafram, Ford Motor Company, Bare Material Sciences, Clean Cut Technologies, Cadence Manufacturing
Also
AAMI, ISO 13485, FDA

Other shows on the same ground, closest first.

  • Embedded.fm · 1h 04m

    305: Humans Have a Terrible Spec Sheet

    Amanda Wozniak, a principal engineer at Amazon Robotics with a background at Analog Devices, the Wyss Institute at Harvard, and NxStage, discusses her career path from semiconductor design to biomedical engineering and robotics. She explains the critical gap between academic theory and practical engineering, highlighting how parasitics and non-ideal component behavior often cause circuit failures that textbooks ignore. Wozniak also details the challenges of navigating FDA regulatory processes for medical devices and the importance of establishing robust quality systems early to avoid bureaucratic busywork. Finally, she addresses the realities of being a woman in tech, offering advice on handling sexism, avoiding burnout, and recognizing that engineering is fundamentally a team sport rather than a solo endeavor.

  • The Amp Hour · 1h 18m

    An Interview with Steve Kreuzer

    Steve Kreuzer, a mechanical engineer and PhD from UT Austin, explains his transition from academic biomechanics to consulting at Exponent, where he analyzes failures in physical products. He details how Exponent uses finite element analysis (FEA) and computational fluid dynamics (CFD) to investigate issues like battery thermal runaway and BGA solder joint failures in electronics. Kreuzer discusses the specific mechanical risks of lithium-ion cells, the importance of protecting cells from environmental stress and containing thermal events, and how simulation guides design fixes like stiffeners and spacing.

  • Let's Combinate · 13m

    215 - Why Aren’t Technical People Leading Drug-Device Audits?

    Subhi Saadeh, Founder of Let’s Combinate BioWorks, explains why engineers in pharma and medical devices should become auditors, arguing that technical expertise combined with audit methodology creates the most effective auditors. He details how auditing provides a system-level perspective, revealing how design decisions ripple through Quality Management Systems (QMS) and identifying systemic root causes that isolated engineering work often misses. Saadeh addresses common misconceptions, such as the view that auditing is merely bureaucratic paperwork, and reframes it as a critical tool for building regulatory fluency and career versatility across industries like aerospace and medical devices. He concludes with practical steps for engineers to enter the field, including shadowing internal audits, learning audit frameworks like ISO 13485, and seeking mentorship from experienced professionals.

  • Global Medical Device Podcast · 44m

    #468: SaMD Issues, Defects & Detection | Shawnnah Monterrey

    Shawnnah Monterrey, founder of Beanstalk Ventures and an FDA-accredited third-party reviewer, discusses post-market quality issues in medical devices, drawing on her experience at ZEISS and Illumina. She explains how inadequate upstream characterization, such as neglecting shipping stresses or subsystem-level DFMEAs, leads to costly 'dead on arrival' failures and field complaints. The conversation highlights the importance of robust unit testing, clear design documentation, and structural post-market surveillance to prevent catastrophic recalls, using a Class 1 ventilator case study to illustrate software-hardware interaction failures. Monterrey also addresses the challenges of integrating AI-generated code into maintainable systems and the critical need for open communication loops between R&D, manufacturing, and post-market teams to feed field intelligence back into product design.

  • Manufacturing Happy Hour · 42m

    How Stylish Steel-Toe Shoes are Empowering Women in Industry | An Interview with Xena Workwear CEO Ana Kraft

    Ana Kraft, Co-Founder and CEO of Xena Workwear, explains how she identified a gap in the market for stylish, compliant steel-toe footwear for women after struggling with bulky, masculine designs during her career in project management. She details the company's journey from prototyping to launch, highlighting the technical challenges of meeting ASTM safety standards, including slip, chemical, and static dissipative resistance. Kraft discusses the broader mission of Xena Workwear to empower women in STEM and industrial fields by boosting confidence through professional appearance, while also outlining upcoming expansions into functional apparel like blazers with integrated safety features.

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Being an Engineer. The episode itself belongs to its publisher.