S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements
Being an Engineer19 Juli 2024

S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements

Send a text Steve 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 syste...

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S1E15 Robot Cinematography, 16-day Ventilators, & Identifying the REAL problem | Russ Aldridge

S1E15 Robot Cinematography, 16-day Ventilators, & Identifying the REAL problem | Russ Aldridge

Send a text Russ Aldridge and cofounder Marc Christenson started Sisu in 2010 as an integrator for their former employer NI (National Instruments). They have expanded the company far beyond just NI an...

19 Juni 202048min

S1E14 An Engineer’s Engineer | Robert Futch

S1E14 An Engineer’s Engineer | Robert Futch

Send a text Robert grew up building Legos, toy rockets, fixing vehicles, and developing video games…it seemed inevitable that he would become an engineer. As CTO at Delta Development Team, he continue...

19 Juni 202043min

S1E13 A Holistic View on Product Development | Devon Campbell

S1E13 A Holistic View on Product Development | Devon Campbell

Send a text Devon Campbell is the founder and Managing Director of Prodct LLC. Prodct is a Boston-based, boutique advisory firm focused on helping emerging entrepreneurs and early-stage biotech, medi...

9 Juni 202051min

S1E12 Simplifying Quality Management | Jon Speer

S1E12 Simplifying Quality Management | Jon Speer

Send a text Early in his career Jon was spending too much time updating the team’s Excel spreadsheet which they used to track quality and regulatory-related progress during device development phases. ...

5 Juni 202037min

S1E11 Farm Boys Make the Best Engineers | Tommy Davis

S1E11 Farm Boys Make the Best Engineers | Tommy Davis

Send a text From welding together home-grown farm tools to sophisticated statistics for assessing risk management, hear how Tommy Davis has progressed his career as an engineer. Also, learn first hand...

3 Juni 202040min

S1E10 From Engineering Startups to Established Corporations | Patrick Stephens

S1E10 From Engineering Startups to Established Corporations | Patrick Stephens

Send a text What’s it like working in a small engineering startup vs a large established corporation? How do you motivate your engineering team? What are the most important skillsets for engineers to ...

29 Maj 202041min

S1E09 Engineering Starts With Why | Alex Kim

S1E09 Engineering Starts With Why | Alex Kim

Send a text From engineering roles at iRobot to Sensata to Thermo Fisher Alex shares with us the top skills that product designers need, the importance of understanding your “why”, and his mission to ...

26 Maj 202048min

S1E08 Getting laid off and starting an engineering company | Aaron Moncur

S1E08 Getting laid off and starting an engineering company | Aaron Moncur

Send a text In 2009 Aaron was laid off from his job as a mechanical engineer designing medical devices. Instead of finding another job he started Pipeline Design & Engineering, figured out how to deve...

20 Maj 202036min

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