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battleship81
Mechanical
Hello-
I have to start by saying that this might not be the correct place to post this, but I couldn't find a more appropriate place in my searches.
So here's the deal:
I recently took a job as the sole mechanical engineer for a small medical device OEM, and we basically run things like we're stuck in the 1980s - meaning lots of laborious analog work, and time consuming, super inefficient, seemingly repetitive processes. We would like to modernize and we'd like to go about things the best way possible.
A few noteworthy facts:
-We use Solidworks for our design and drawing creation, but we have no document manager to keep things organized. This is all done manually in Windows explorer.
-As I said, we are a medical device company, so we are FDA regulated in our documentation of our processes.
-Currently, we still complete ERs all by hand.
-There are currently no official policies or procedures in place to guide us through the engineering design and release process.
-Although I have 5 solid years of good product development, I unfortunately have limited experience with efficient and modern systems for document and process control.
-That limited experience does include working under a "Bible" of engineering policies and procedures, which I could draw from in formulating a "Bible" here.
-I have experience with PDMWorks and I know that it's one program that we could definitely utilize for document control and ER completion, etc., but there may be better programs out there.
-We use PCMRP for our manufacturing and inventory control, and it's just terrible. Something that would play well a document control package, SolidWorks or both would be nice.
I know there's more info I could give but I think that's enough to get started.
Can anyone provide any helpful info?
Many thanks!
I have to start by saying that this might not be the correct place to post this, but I couldn't find a more appropriate place in my searches.
So here's the deal:
I recently took a job as the sole mechanical engineer for a small medical device OEM, and we basically run things like we're stuck in the 1980s - meaning lots of laborious analog work, and time consuming, super inefficient, seemingly repetitive processes. We would like to modernize and we'd like to go about things the best way possible.
A few noteworthy facts:
-We use Solidworks for our design and drawing creation, but we have no document manager to keep things organized. This is all done manually in Windows explorer.
-As I said, we are a medical device company, so we are FDA regulated in our documentation of our processes.
-Currently, we still complete ERs all by hand.
-There are currently no official policies or procedures in place to guide us through the engineering design and release process.
-Although I have 5 solid years of good product development, I unfortunately have limited experience with efficient and modern systems for document and process control.
-That limited experience does include working under a "Bible" of engineering policies and procedures, which I could draw from in formulating a "Bible" here.
-I have experience with PDMWorks and I know that it's one program that we could definitely utilize for document control and ER completion, etc., but there may be better programs out there.
-We use PCMRP for our manufacturing and inventory control, and it's just terrible. Something that would play well a document control package, SolidWorks or both would be nice.
I know there's more info I could give but I think that's enough to get started.
Can anyone provide any helpful info?
Many thanks!