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

- Show: [Being an Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer)
- Published: 2026-02-06
- Length: 42m
- Episode: 6
- Page: https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=0) Introduction: Bob Hankins and TE Connectivity
- [1:32](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=92) Early Influences and Career Path
- [3:43](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=223) TE Connectivity's Medical Device Strategy
- [5:25](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=325) Lessons from Startup Recalls and PFMEA
- [9:49](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=589) Transition to Interim CTO and Leadership
- [12:55](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=775) Prioritization and Risk Mitigation Strategies
- [14:30](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=870) Navigating Regulatory Requirements and Pitfalls
- [17:55](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=1075) Advice for Engineers Seeking Leadership
- [22:49](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=1369) Communication, Miscommunication, and Business Acumen
- [28:40](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=1720) Empowering Engineers and Culture of Excellence
- [30:56](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=1856) System-Level Thinking and FDA Interactions
- [35:58](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda#t=2158) Managing Stress and Work-Life Balance

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

large enterprises

## Mentioned

- TE Connectivity (company)
- Nordson Medical (company)
- Clorox (company)
- ISO 13485 (other)
- ISO 14971 (other)
- FDA (other)
- PFMEA (other)
- DFMEA (other)

## Related episodes from other shows

- [009 - “Cutting Through the Noise” with Charles Ventura](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-01-009-cutting-through-the-noise-with-charles-ventura) (Let's Combinate)
- [Meet a Guru: Ryan Behringer](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-14-meet-a-guru-ryan-behringer) (Global Medical Device Podcast)
- [135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su) (Let's Combinate)
- [How Jon Speer Met His Most Frequent Guest: Mike Drues](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues) (Global Medical Device Podcast)
- [Meet a Guru: Wade Schroeder](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-19-meet-a-guru-wade-schroeder) (Global Medical Device Podcast)

## Citing this page

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