Being an Engineer

Send us Fan MailSteve Gompertz discusses the complexities of navigating the regulatory landscape in the medical device industry. He shares insights on the evolution of global regulations, the balance between innovation and quality control, and strategies for developing effective quality management systems for companies of all sizes. Main Topics:Regulatory compliance in medical devicesTailoring quality management approaches for small vs. large companiesThe core components of a quality system and its evolution over timeEmerging trends in medical device regulations, such as AI and cybersecurityImproving quality management systems and achieving regulatory complianceSteve Gompertz is a highly experienced leader in quality systems management and regulatory compliance, currently serving as a partner at QRx Partners. With a career spanning over 30 years, he has held significant roles in various companies, including Pelican Biothermal, St. Jude Medical, Boston Scientific, and Medtronic. At QRx Partners, Steve specializes in quality systems development, project management, and engineering automation, helping companies navigate complex regulatory environments and enhance their quality management systems​Links:Steve Gompertz - LinkedInQRx Partners Website Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Send us Fan MailToday we continue our “Open to Work” series by welcoming Aaron Gebauer. Aaron Gebauer shares his extensive career journey and insights into implementing SolidWorks PDM, managing job transitions, the importance of professional development and networking, and finding balance during uncertain periods. Aaron is now seeking new opportunities to advance engineering teams to higher levels of performance and we are excited to share his extensive experience and insights with the Being An Engineer podcast community.Main Topics:Implementing PDM softwareManaging CAD filesLeadership and risk-taking at startupsJob searchingSelf-careAccelerating engineering through collaboration.About the guest: Aaron Gebauer is an experienced mechanical design engineer and project manager. Aaron brings over 27 years of technical expertise, bold leadership, and a results-driven teamwork approach. Aaron, recently managed teams and established new departmental capabilities.Links:Aaron Gebauer - LinkedIn Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Send us Fan MailAndy discusses his background growing up on a farm and how it shaped his work ethic. He talks about his experience founding Engineering Consultants and working with medical device startups. Key topics include challenges in commercializing devices, balancing an inventor's vision with engineering feasibility, and advice for engineers entering the field.Main Topics: Medical device regulationsChallenges in commercializationBalancing an inventor's visionStem cell and gene therapy advances in ophthalmologyAdvice for young engineers About the guest: Andy Schieber is a seasoned medical device engineer and entrepreneur with extensive experience in research and development. He is the Founder and President of Ingenarious Consultants, a firm that specializes in early-stage medical device development, offering services from concept to clinical trials. Andy has a remarkable track record in designing and developing Class III implantable medical devices, and he holds over 40 patents including the Hydrus Microstent, which is a significant innovation in ophthalmology.He also serves as the Head of Engineering at Rivermark Medical, where he contributes to the development of novel medical technologies. Andy’s educational background includes a Master’s degree in Mechanical Engineering from the University of Minnesota and a Bachelor’s in Engineering from the University of Wisconsin-Stout​.Links:Andy Schieber - LinkedInIngenarious Consultants Website Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Send us Fan MailThe next PDX event is coming up – so mark your calendars for Thursday July 18th…  ...and this one is free (and online)!   In this event, simulation expert and 35 year veteran of the industry Krishna Raichur will teach you the basics of setting up, running, and evaluating results of FEA simulations. You’ll learn how early-stage simulation can help reduce development times, decrease warranty costs, and reduce part weight through topology optimization.  This is not a sales pitch. As with all PDX events, the training will focus on practical skills you can apply to your work right away. Krishna will also be doing Q&A to answer your real-world simulation questions at the end. The webinar will cover:What simulation is and how you can leverage it in your product development workHow you can save time and money for your company by doing simulations early in the product design cycleHow to make “what if” design changes and quickly see their effects on product performanceHow to optimize your design for things like weight, strength, and size. Again, this PDX event is online and happening Thursday July 18. Register for free here. See you there!Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Send us Fan MailPatrick Jreijiri shares his journey in product design, mechanical engineering, entrepreneurship, and growing his freelance product development company. He discusses challenges he overcame like competing with cheaper labor abroad and the loneliness of remote work. Patrick also provides insights on processes like prototyping early and drawing inspiration from different engineering fields.Main Topics:Patrick's background and discovery of his passion for inventionsExperiences starting companies and failed product development projectsChallenges of entrepreneurship like estimating costs and timelines  Automating processes to improve operations dramaticallyInsights on remote work and deciding to hire contractors vs employeesAbout the guest: Patrick Jreijiri is an accomplished entrepreneur and engineering professional with extensive experience in business development, mechanical engineering, and product design. He currently serves as the Founder and CEO of Jiri, a company dedicated to creating innovative solutions in the tech industry. With a strong background in engineering and a passion for technology, Patrick has successfully navigated the challenges of starting and growing his own business, and his insights into remote work, product development, and entrepreneurship make him a valuable guest for the Being An Engineer podcast.Links:Patrick Jreijiri - LinkedInJiri Website  Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Send us Fan MailWelcome to a special episode of the "Being an Engineer" podcast, marking the beginning of our new "Open to Work" series. Part of the stated purpose of the BAE podcast is to “connect with the companies, technologies, people, resources, and opportunities featured on our show.” In alignment with that purpose, my goal for this open to work series is to provide a platform for engineers who are currently seeking new opportunities, sharing their experiences and insights in an open and candid manner to connect these talented professionals with our community of listeners who may be able to offer support or job leadsOur first guest in this series is Erica Kahn, she is here to share her journey, discuss the challenges of being unexpectedly out of work, and provide valuable insights that can benefit engineers who may find themselves in a similar situation.We are honored to have her kick off this important series. Through her candid discussion, we hope to provide not only a connection for Erica but also a source of inspiration and practical advice for our listeners.Main Topics:Erica's work developing hydrogel technologies for eyecareCreativity in engineeringCoping with job lossLeveraging her networkCareer development after being laid offAbout the guest: Erica Kahn, is a highly accomplished biomedical engineer with a wealth of experience in the medical device industry. Erica previously worked for Ocular Therapeutix, where she made significant contributions to the development of innovative hydrogel technologies for ocular applications. Links:Erica Kahn - LinkedInEmail - Ekahn92@gmail.com  Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Send us Fan MailIn this episode, we delve into Dion's remarkable journey in medical device manufacturing. We explore his wealth of experience and expertise, spanning crucial aspects such as product development, regulatory submissions, and the implementation of various manufacturing technologies.Main Topics:Pneumatic welding process challenges and qualificationsBest practices for developing and optimizing nitinol welding processes  Experience overcoming a tough FDA regulatory hurdlePrinciples for mentorship, failure, and learning in engineeringEvaluating and implementing new technologiesSkills required for today's manufacturing engineersAbout the guest: Dion Lopes is an accomplished engineering leader with a deep track record in the medical device industry. Dion's career highlights include key roles at several top organizations, such as Director of Manufacturing Engineering at Imperative Care, Senior Manager of Manufacturing and Production at Intersect ENT (now part of Medtronic), and various leadership positions at PneumRx and Ortho Clinical Diagnostics. Links:Dion Lopes - LinkedIn  Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Send us Fan MailThe episode discusses Jim Cuseo's engineering journey and lessons learned over his career. He shares insights on defining requirements, developing complex products, scaling operations, and leading large teams.Main Topics:Defining clear product requirementsDeveloping subsystems while considering broader context Accelerating engineering through effective processesCommon mistakes and how to avoid themEmerging technologies impacting designAbout the guest: Jim Cuseo is a seasoned mechanical engineer whose remarkable career has spanned over two decades, influencing the design of some of the most iconic technology products. James's journey began at the prestigious Massachusetts Institute of Technology and led him through pivotal roles at Ford, Exponent, and MagCanica, where he honed his skills in the motorsport and aerospace sectors. Next, Jim spent over a decade at Apple, where he grew to Director of Mac Product Design, overseeing the development of groundbreaking products such as the 16” MacBook Pro and the iMac with Retina Displays. Currently, he offers his expertise to various companies through his consultancy, Jim Cuseo, LLC, aiding them in scaling operations and enhancing product designs. Links:James Cuseo - LinkedIn Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Send us Fan MailWelcome to another episode of the Being An Engineer podcast. Today, we're excited to host James Trevelyan. James shares insights from his extensive research and experience on effective collaboration, cultural differences in engineering practice, value creation, and accelerating engineering development through experimentation. Main Topics:Engineering collaboration skillsCommunication vs emailCultural impacts on innovationProject failures due to collaboration issuesImproving listening skillsTraining prioritiesCreating value for clients.About the guest: James Trevelyan, is a renowned engineer whose career spans significant contributions to both academia and industry. James's work has profoundly impacted practical engineering applications and education, notably in areas of robotics and automation. His extensive research and development projects have pioneered technological advancements and provided critical insights into engineering practice. With a focus on enhancing the utility of engineering work and its recognition in society, James offers invaluable perspectives on navigating and succeeding in the engineering world.Links:James Trevelyan LinkedInWebsiteBook Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Send us Fan MailChris shares his invaluable insights and experiences from his remarkable 35+ year career in medical device innovation. He discusses how he got into engineering without a formal degree, his early career path working at startups in Silicon Valley, and advice for others looking to get into engineering.Main Topics:How Chris got into engineering through curiosity and building things rather than deciding on it as a careerHis early challenges in math but passion for science and technologyHis first medical device job at a startup building test equipmentAdvice for getting into engineering without a degree by learning on the job.  About the guest: Chris is an accomplished leader in the field of engineering, boasting a robust background in project management and development within the medical devices sector. His impressive career includes roles at notable companies where he has led teams through complex projects, pushing the boundaries of innovation and efficiency. As someone who's navigated the fast-evolving terrain of medical technologies, Chris brings a treasure trove of insights on career acceleration, leadership, and adapting to the technological shifts in engineering.Links:Chris Julian - LinkedInChris’ Websites Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus