Hardware Podcasts

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

Being an Engineer · 6 Feb 2026 · 42m · Episode 6

What this episode covers

Bob Hankins, Director of Engineered Component Development at TE Connectivity, discusses leading global engineering teams in the regulated medical device space, focusing on complex components like catheters and structural heart devices. He shares lessons from his early career at a startup ventilator company, where recalls and FDA interactions taught him the critical value of PFMEA, DFMEA, and rigorous risk-based design processes. Hankins emphasizes the importance of balancing innovation with manufacturing rigor, advocating for a leadership style that empowers engineers through clear guardrails while maintaining strict compliance with ISO 13485 and FDA requirements.

Most relevant to

large enterprises

Topics

Mentioned

Companies
TE Connectivity, Nordson Medical, Clorox
Also
ISO 13485, ISO 14971, FDA, PFMEA, DFMEA

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