# S1E35 Harley-Davidson, Device Reprocessing, & Keeping a High Level Perspective | Tim Rempfer

- Show: [Being an Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer)
- Published: 2020-09-04
- Length: 44m
- Episode: 35
- Page: https://hardwarepodcasts.com/podcast/being-an-engineer/2020-09-04-s1e35-harley-davidson-device-reprocessing-keeping-a-high-level-perspective-tim-r
- Listen: https://teampipeline.us/harley-davidson-device-reprocessing/

## Summary

Tim Rempfer, a senior engineer at Medline Renewal, discusses his career path from designing custom Harley-Davidson components at Sputhe Engineering to reprocessing one-time-use medical devices. He details the technical challenges of reverse-engineering OEM devices to meet FDA equivalence standards and the complexities of designing a new manufacturing facility. Rempfer emphasizes the importance of maintaining a high-level perspective to avoid tunnel vision and shares lessons on professional distance and knowing when to ask for help in high-stakes engineering environments.

## Chapters

- [0:14](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-09-04-s1e35-harley-davidson-device-reprocessing-keeping-a-high-level-perspective-tim-r#t=14) Introduction and Early Life
- [6:12](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-09-04-s1e35-harley-davidson-device-reprocessing-keeping-a-high-level-perspective-tim-r#t=372) Designing Custom Harley-Davidson Parts at Sputhe Engineering
- [23:05](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-09-04-s1e35-harley-davidson-device-reprocessing-keeping-a-high-level-perspective-tim-r#t=1385) Transition to Medical Device Reprocessing at Medline
- [31:05](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-09-04-s1e35-harley-davidson-device-reprocessing-keeping-a-high-level-perspective-tim-r#t=1865) Designing a New Manufacturing Facility
- [36:38](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-09-04-s1e35-harley-davidson-device-reprocessing-keeping-a-high-level-perspective-tim-r#t=2198) Career Lessons and High-Level Perspective

## Topics

- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

companies scaling up, large enterprises

## Mentioned

- Harley-Davidson (company)
- Sputhe Engineering (company)
- Medline Renewal (company)
- FDA (other)
- Pipeline Design & Engineering (company)

## Related episodes from other shows

- [305: Humans Have a Terrible Spec Sheet](https://hardwarepodcasts.com/podcast/embedded-fm/2019-10-03-305-humans-have-a-terrible-spec-sheet) (Embedded.fm)
- [A Look Inside Medical Device Manufacturing with Philips’ Natalia Mendez](https://hardwarepodcasts.com/podcast/manufacturing-happy-hour/2022-09-27-a-look-inside-medical-device-manufacturing-with-philips-natalia-mendez) (Manufacturing Happy Hour)
- [#461: Why Manufacturing is Part of Product Development with Mike Dolphin](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-22-461-why-manufacturing-is-part-of-product-development-with-mike-dolphin) (Global Medical Device Podcast)
- [Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-should-design-controls-have-prevented-the-recent-reprocessing-tragedy-do-we-need) (Global Medical Device Podcast)
- [127 - "If we do our job, no one will know" with LeRonda Perry](https://hardwarepodcasts.com/podcast/people-of-packaging/2022-04-27-127-if-we-do-our-job-no-one-will-know-with-leronda-perry) (People of Packaging)

## Citing this page

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