The glamorous life of a medical device engineer

What I did today:

Got in early, ate breakfast bars while deleting junk mail. I email the biocompatibility testing lab and tell them its on, we sent samples yesterday, Merry Christmas. Let me know if there is anything you need from me, blah blah blah.

Looked at the pallets we got back from the sterilizer yesterday with a couple of the guys from manufacturing, remove the pallet wrap and organize the boxes. Complain about their condition due to our choice to not use a master carton. I send an email to the shipping testing place, tell them the box count and the PO number.

Went to talk to my boss, inform him that the 2 pallets we got from the sterilizer need to be inspected before 9:30 when they are scheduled to be driven over to shipping simulation by the president of the company- he's got the truck. I tell him he's the only quality rep here now, hint hint hint, boss says wait for QC. I look at him like he's crazy.

Walk over to the lab, see the manufacturing manager looking at the pallets, he decides to get his guys making boxes. In the lab I start setting up for today's test, a comparison of hemolysis done by our device and predicate device to make sure we're on the same page. The lab tech and I have got the test aced, we just want one more practice before the real deal. The software engineer calls, want to talk about a flowchart I wrote up for the product, I tell him I'll call him back.

QC arrives at 8:45, panics. President arrives at 9, asks me if we're ready to go, I refer him to QC, he accuses me of passing the buck.

At 10, the QA arrives with the blood for today's lab test. I start working on blood prep. QA dept starts repackaging product that needs it. I go over there and see they're using uncontrolled packaging tape, mention it, they look at me like I'm crazy. I go back to work in the lab. We get the test started around 11, I go check my email.

Testing lab wants 50% payment and has sent a bunch of standard protocols for sign off. I consider reading them then forward them to QA before I sign and fax them back. I harass the secretary to get the check and get it signed by the president who is going to buy a tarp because its raining now. I Fedex the check.

I go back to the lab, clean up, work on the hemolysis test and quickly set up a side project for my boss. QC comes over and accuses me of "not helping" I count 3 quality people and 2 manufacturing working on it, how much help do they need? I volunteer to print labels, print them, then go back to the test. Boss and other engineer come over to the lab to work on the side project, apparently this involves standing directly in front of the much used centrifuge.

12:30, the other engineer orders and gets a pizza and along with the lab tech, we eat it in the warehouse while watching the testing in the next room. We watch manufacturing and QC run around I look at the two pallets balanced in the pickup skeptically, now I wish I would have taken a picture. The president leaves for the shipping lab, we get back to work.

Software engineer calls, I tell him I'll call him back. Manufacturing manager gets me on the phone with the print shop who want to know how many staples and paper type (umm, white?) for the IFU, he then tells me we're definitely moving. We finish up the test and clean up. 3:00, I go to my desk, call the software engineer, discuss software, he tells me he pulled an all nighter last night, I feel bad because I don't see much progress.

I go back to the lab, set up the overnight experiment, finish filling out today's test data. President comes back, tells us we have no idea how to tie a load down onto a pickup, it was all messed up by the time he got there. I tell him we need to pick it back up on Monday. I start the overnight experiment, go back to my desk. I call the shipping lab, they say they might be done tomorrow, I decide to surprise the president with the good news if it pans out tomorrow and not tell him today. I print out two ECNs that I finished yesterday but didn't get to, sign them and put them on QCs desk. QC asks me if I want an email summary of damaged boxes, I tell her "no."

I go back to my desk, check my email, boss has sent me a subjectless email containing only this: " http://www.fda.gov/cdrh/ode/guidance/337.html "--What could it mean? I consider forwarding it to QC. Voice mail from a sterilizer, I call them back and talk about some testing. 4:30 go home!