From Eric Hinrichs

Articles to get your mind going

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June 13, 2023
The Importance Of Risk Documentation In Medical Device Design

It’s a great day for hiking in the woods. The sun is shining, the temperature is just right, and the calmness of the forest is relaxing. After a time, you come to a stream that’s swollen from rain the day before. You have to cross the stream, but you have no way of knowing how […]

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June 13, 2023
3 Common Mistakes Using Gantt Charts For Medical Device Projects

In this series of articles, I’ll touch upon areas that I’ve found to be practical advice for project leaders. This article will focus on project planning. Hopefully, the points made will benefit you in supporting or running your next project. As project leader you need to develop a project plan for your team to track […]

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June 12, 2023
Quality Engineers: Are You Making The Right Call?

by Eric Hinrichs, senior principal quality engineer (retired), Ethicon, part of the Johnson & Johnson Medical Device Companies As a quality engineer, have you ever had the following conversation with a project leader?Project leader: “Hey, do you have a minute?”You: “Sure, what is it?”Project leader: “Well, we need your signature on this validation completion report. […]

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March 25, 2023
The Role of the Project Leader- The Team

Which are the true statements about a project leader? Unfortunately, these statements are often viewed as the true role of a project leader. I’ve experienced and been a part of many teams where the above statements were truths. I’ve learned there is no magic formula or process that is foolproof in achieving a successful project […]

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March 25, 2023
The Role of the Project Leader- Execution

This article focuses upon project execution. The points made will benefit project leaders in avoiding pitfalls that could impact a project’s success. Now that you’re a project leader, your job is to get the project done as soon as possible and get it done right; management is already breathing down your back. Quickly, you assemble […]

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March 24, 2023
The Role of the Project Leader- Project Planning

This article focuses upon practical advice for project leaders and project planning. I hope the points made will benefit you in supporting your current project or running your next project. Now that you’re a project leader, your job is to get the project done as soon as possible and get it done right; management is […]

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January 18, 2023
The Role Of Trust And Communication In Successful Medical Device Teams

If you work in the medical industry, you know that new products, revisions, and updates to existing products are typically accomplished by teams. Teams can range from small groups of technical experts to elaborate team structures that are spread out over several company facilities and key suppliers. But why do we experience teams that seem […]

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January 18, 2023
Statistics Abuse In QA/QC: 3 Lessons Learned

The tools we use to develop new or improved products are essential in ensuring we deliver the product as soon as possible and as efficacious as technology, testing, and knowledge/experience permits. But the caution one must take in using tools is to be mindful that we use the tools correctly and effectively. The worst that […]

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January 18, 2023
Continuity Is the Key to Success for Your Medical Device Company

Continuity, by definition, is the state or quality of being continuous. To a company, continuity could be the ability to provide a product that consistently performs as expected with consistent quality. It could also refer to a company’s ability to consistently make a product available without supply chain disruption. Financially, continuity could refer to a […]

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Perceptions and Expectations
By: Eric Hinrichs

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