# E94 Requirements Engineering, part 1: Fundamentals

- Show: [The Pragmatic Embedded Podcast](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast)
- Published: 2026-04-15
- Length: 47m
- Page: https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals
- Listen: https://agileembeddedpodcast.com/episodes/e94-requirements-engineering-part-1-fundamentals-PSeTSsKz

## Summary

Jeff Gable, a medical device consultant, and Luca, with automotive and aerospace experience, discuss the fundamentals of requirements engineering for safety-critical products. They explain the hierarchy from user needs to system requirements, emphasizing the EARS format and the critical distinction between verifiable requirements and design choices. The hosts argue against using Word or Excel for complex traceability, advocating instead for dedicated requirements management tools to ensure regulatory compliance and engineering rigor.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals#t=1) Introduction: Jeff Gable and Luca on Requirements Engineering Fundamentals
- [3:37](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals#t=217) Agile vs. Waterfall: Why Requirements Matter Even for Agilists
- [7:48](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals#t=468) The Hierarchy of Requirements: User Needs vs. System Requirements
- [11:18](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals#t=678) Distinguishing Requirements from Design Choices
- [19:51](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals#t=1191) Writing Good Requirements: EARS Format and Glossaries
- [24:08](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals#t=1448) Traceability: Linking Requirements to Test Cases and Avoiding Word/Excel
- [29:57](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals#t=1797) Risk Analysis and Documentation as an Artifact of Diligence
- [42:24](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals#t=2544) Using LLMs to Build Tools, Not Manage Requirements

## Topics

- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- FDA (other)
- EARS (other)
- ISO 26262 (other)
- DO-178B (other)
- Claude Opus (other)
- Notion (other)
- Oshlin (other)

## Related episodes from other shows

- [67: Software for Things That Can Kill People](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people) (Embedded.fm)
- [Altium Requirements Portal: Simplifying Engineering Docs](https://hardwarepodcasts.com/podcast/ontrack/2025-12-16-altium-requirements-portal-simplifying-engineering-docs) (OnTrack)
- [V&V Activities from a Verification Engineer POV - How Hard Could It Be?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be) (Global Medical Device Podcast)
- [53: Being a Grownup Engineer](https://hardwarepodcasts.com/podcast/embedded-fm/2014-05-28-53-being-a-grownup-engineer) (Embedded.fm)
- [Setting the Record Straight on Usability & Human Factors](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors) (Global Medical Device Podcast)

## Citing this page

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