Danny Smith | Interviewing Engineers, Managing Engineering Budgets, & Technical Writing

Being an Engineer · 14 Oct 2022 · 47m · Episode 39

What this episode covers

Danny Smith, R&D Manager at Fluidics Medical Technology, discusses his 20-year career in medical device engineering, highlighting the critical role of technical writing and cross-functional collaboration. He shares insights on managing engineering budgets by leveraging experience to predict unforeseen costs, such as mold rework, and emphasizes the importance of balancing perfection with practical constraints. Smith also details his approach to hiring and leadership, advocating for engineers who can work unsupervised, communicate effectively, and challenge assumptions to drive innovation.

Mentioned

Companies
Fluidics Medical Technology, Becton Dickinson, Specialized Health Products International, Bard Access Systems, Pipeline Design & Engineering
Products
Mini Lock Safety Infusion Set
Also
ISO 13485, Extreme Ownership

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 39m

    #470: The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova

    Lisa Voronkova, co-founder of OVA Solutions, draws on data from over 200 medical devices to outline the real costs and timelines of MedTech innovation. She details four engineering phases—Discovery, Proof of Concept, Design, and Development—and provides specific hour estimates for projects ranging from simple electronics to complex continuous glucose monitors (CGMs). Voronkova emphasizes the critical importance of validating devices in real clinical environments and explains why Design for Manufacturability (DFM) requires significant additional engineering investment to avoid costly late-stage redesigns.

  • 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.

  • 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 · 35m

    Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

    Devin Mack, mechanical engineer and owner of Enqual, discusses the critical importance of defining and managing requirements in medical device product development. He argues that companies should spend approximately one-third of their project time on this phase to avoid chaos and ensure market fit. Mack advocates for early cross-functional involvement from quality, manufacturing, and regulatory teams, rather than siloed engineering efforts. He also shares his 'stoplight' methodology for tracking progress against customer specifications and emphasizes the need for usability models to get it right the first time.

  • Product Startup · 35m

    082: Smooth Product Flow from Visual Design to Engineering

    Robert Irwin, former Lead Industrial Designer at Amazon for the Amazon Dash Cart, explains how industrial design and mechanical engineering teams can collaborate effectively to avoid costly rework. He advocates for an early, iterative 'ping pong' process where engineers and designers brainstorm constraints and user needs simultaneously, rather than passing work linearly 'over the fence.' Irwin emphasizes that dedicated project management and frequent stakeholder communication are essential to aligning technical feasibility with customer value before tooling begins.

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.