S1E17 Precise Speech, Customer Success, & General Engineering Love | Jesseca Lyons

Being an Engineer · 26 Jun 2020 · 52m · Episode 17

What this episode covers

Jesseca Lyons, a mechanical engineer and customer success expert at Greenlight Guru, discusses her passion for engineering, particularly in the medical device sector. She explains how she uses precise documentation and design controls to ensure safety and efficacy, drawing on experiences at Beckman Coulter and CRI. Lyons emphasizes the importance of understanding the 'why' behind customer requirements, such as a specific color choice for a device handle, to avoid misinterpretation and ensure the final product meets the intended perception of quality. She also shares insights on design for manufacturability, highlighting the challenges of assembling complex tubing systems and the need for clear, unambiguous instructions to reduce labor costs and errors.

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 37m

    Meet a GURU: Jesseca Lyons

    Jesseca Lyons, a Senior Medical Device Guru at Greenlight Guru with a mechanical engineering background from Rose-Hulman and experience at Beckman Coulter, discusses the critical role of design controls and risk management in medical device development. She explains how she transformed her view of risk management from a tedious burden into an engaging process by using relatable analogies like ice cream and Sharknados to explain probability and hazardous situations. Lyons emphasizes the importance of documenting design decisions early to avoid costly remediation and shares her passion for helping customers navigate audits and regulatory hurdles to improve patient quality of life.

  • Global Medical Device Podcast · 28m

    Meet a Guru: Laura Court

    Laura Court, a medical device Guru at Greenlight Guru, discusses her journey from mechanical engineering and hands-on manufacturing roles to her current position helping companies navigate regulatory workflows. She emphasizes the critical importance of understanding manufacturing processes during the design phase, citing her experience with high-intensity focused ultrasonic probes and large-scale production of over 8 million parts. Court highlights the value of collaborating with floor workers and leveraging resources like the Greenlight Guru Academy to avoid common pitfalls in design controls and risk management.

  • Global Medical Device Podcast · 34m

    #378: Who Owns the Design Controls Process?

    Laura Maher, a design assurance professional at Greenlight Guru, discusses the critical role of ownership in medical device design controls with host Etienne Nichols. They explore the concept of a 'design assurance professional' who bridges the gap between product development, quality, and regulatory teams to create clear, audit-ready documentation. The conversation covers the importance of understanding user needs, the collaborative nature of risk management, and the distinction between technical design reviews and broader stage reviews.

  • Global Medical Device Podcast · 42m

    Determining User Needs for Your Medical Device

    Jesseca Lyons, a mechanical engineer and regulatory expert at Greenlight Guru, discusses the common pitfalls of defining user needs in medical device design controls. She explains how to distinguish true user problems from premature solutions using root cause analysis and emphasizes the importance of cross-functional input to identify who the actual users are. Lyons also clarifies the relationship between user needs and design inputs, noting that not every design input requires a corresponding user need and that design inputs should define performance requirements rather than specific solutions.

  • Global Medical Device Podcast · 27m

    Meet a Guru: Ryan Behringer

    Ryan Behringer, a Training and Onboarding Medical Device Guru at Greenlight Guru, discusses his journey from a biomedical engineering student at the University of Cincinnati to a product development engineer at an Omaha startup. He explains how he used the Greenlight Guru platform to manage design controls and risk management, successfully achieving 510(k) clearance for his device. Behringer emphasizes the importance of integrating quality and regulatory knowledge early in the engineering process to avoid checkbox compliance and ensure true product value. He now helps other companies implement these systems to streamline their path to market.

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