SEP Internship Program Journal Entries

Journal Entry 1
Friday, July 22nd - Sunday, August 14th

Hours *
2 hours

Two Week Recap *

I interviewed for my internship on the first day and I was shown around the facilities as
well. I have been in several interviews before and was not incredibly nervous. Finding my way to
and around the internship site was a struggle and while I was expecting an office space, four
huge buildings welcomed me when I drove through the gates. Finding the front desk was hard,
but I asked one of the employees after a while of searching and soon found my way. Aaron, my
mentor, made the interview easier by asking simple and close ended questions so my nerves
would not get the best of me. Overall the entire process made me more excited to intern at
SynCardia and I'm excited to continue my interning experience!

Describe the physical make-up of your internship site. *

My internship site is generally big, but not enormous. The site is segmented off from the
rest of the area by a chainlink fence that is only open for certain time The layout of my
internship is divided into sections based on purpose. For instance the building I work in is strictly
used for engineers and the quality department. This is reciprocated in the front
building/financials and manufacturing and even the SPUS (Segmented Polyurethane Solution)
lab. In the building I intern in, the space is divided by cubicles. There are not very many
windows or doors, but there is a work room and a distinctive paint smell to the area.

How does the physical make-up of your internship impact the

day-to-day operation? *
My internship is directly influenced by collaboration. The space is organized by
specialized groups so that this collaborative effort is more effective, plus the building are fairly
close together, making it easier to visit different departments. It helps a lot that all the people I
need to talk to or work with are fairly close and all other facilities are a few feet away. Cubicles
allow for distance between employees and it is not uncommon to find these work spaces
decorated with personal pictures or even funny online pictures thumb-tacked to the walls. There
are badge scanners on all the doors to keep the public and unauthorized personnel out of the
working areas. The lab space is sectioned off as well, most likely designed to keep the area
clean and dirt away from the clean room itself.
Industry Specific Vocabulary *
SPUS (Segmented Polyurethane Solution) - an elastic-like substance that is inserted in
all hearts. I was introduced to the word when I first visited the SynCardia space during a SPUS
lab tour. The material is vital to the operations of the artificial heart and is truly one of a kind.
Journal Entry 2
Monday, August 15th - Sunday, August 28th

Hours *
0 hours

Two Week Recap *

Recently, I worked over the holidays at my internship site. It was the day before
Thanksgiving and hardly anyone was in the office. Doors were closed and cubicles empty and
the parking lot was bare, but still there was a handful of people working. My mentor was not at
the site, but I knew what I had to do. The most troublesome part of the day was leaving. I had
never seen the gates close before at my internship and I was not sure how to open them. I
drove around the entire site looking for an alternate exit, but then realized the gate was on a
sensor.

What are the expectations for your character and personality at your
internship location? *
It is always important to maintain a professional physique at work. However, the site I
intern at is more laid back then that and conversation is pretty casual. Emails around the plant
are exchanged frequently regarding holiday parties and various PSAs. Phone calls are also
another important medium and everyone around you is always willing to help. Employees are
expected to do their work (as is expected), but this does not stop them from cracking a joke
every now and again. It is a more relax atmosphere versus what I expected going first interning
at the company.

Is this a natural fit for your character/personality or do you have to

actively work to meet these expectations? Why? *
When I first received my internship I was not sure it was the best fit. However,
after having worked at my site for a few months I am finding interest in the material. My
personality does not perfectly fit with the job description, but it does not mean I do not
like what I do. I enjoy challenging myself and learning new things and the medical
industry is constantly evolving and that is my biggest reason for interest in the field.
When I entered the lab space on one of my interning days, I felt truly at home and
engaged in what was happening. Although the quality department is interesting, I feel
like another part of the bigger picture might be a better fit for a lifelong career.
Industry Specific Vocabulary *
Sterility Assurance Level (SAL)--probability of a single variable microorganism occurring
on an item after sterilization. Interning in the quality department a lot of precautions have to be
taken so that the product has little room for error. SAL has to be low in order to assure a quality
artificial heart.
Journal Entry 3
Monday, August 29th - Sunday, September 11th

Hours *
0 hours

Two Week Recap *

I had to write a GAP Analysis for my internship recently. Before the experience, I had no
idea what a GAP Analysis was or how to conduct one, but with a few examples I was starting to
understand the process. I was shown a GAP Analysis that my mentor was working on and told
to continue it. The analysis showed two different FDA policies one from 2007 and one from
2014, and it was my job to find any differences in wording, section changes, etc. and determine
whether gap was present or not. I had never done anything like this before and I was hesitant to
start, but I soon felt pretty comfortable. I really like working on a variety of things and I am glad I
have had the opportunity to branch out and try more than just one task, but multiple.

In what ways have you been able to apply what you have learned in
your academic coursework (classes) to your internship? *
One of my favorite classes I have taken at my school is biology. It was an honors class
and I was engaged in every aspect--from anatomy to organic chemistry to the human genome.
This class has inspired me to go into a medical field and profession and interning with
biomedical devices opens this career path in new, interesting ways. When I first started my
internship I had to understand the processes that are related to the heart that is manufactured. I
had to use not only knowledge from my biology class, but also from my calculus and related
math classes. There is a fair amount of math involved with the process and I am grateful that I
took all those prerequisite classes beforehand to prepare me for SynCardia.

Describe a specific situation in which you applied academic

knowledge to your duties at your internship site. *
When I first started my internship, I had to complete copious amounts of training. One of
these various forms of training was one on one with my mentor to understand the sterilization of
the TAH-t before I entered the lab space. I had to understand the dilutions of solution and how
they affect the CFUs on the heart directly. My Calculus and Algebra II classes prepared my
math skills for such a task. Before starting, I did not fully understand the use of math in the
quality industry, but now I do. This knowledge is then applied to my grasp of the SynCardia
system and further classes I want to take.

Industry Specific Vocabulary *

Colony Forming Unit (CFU)--the estimated number of viable bacteria in a cell sample.
Colony forming units are found through a series of math and data. When sterilizing the artificial
hearts CFUs are an important part of determining the viability of these products.
Journal Entry 4
Monday, September 12th - Sunday, September 25th

Hours *
6 hours and 45 minutes (6.8 hours)

Two Week Recap *

Most recently, I have had to undergo a training process using a system practiced by everyone who
works at SynCardia. The training is used to familiarize myself with the processes and terminology known to
employees of SynCardia. This training ranges from report writing to signature records and even quality
statement of assurances. During this time, my mentor, Aaron Spinogatti, has taught me one-on-one with
some of the harder concepts to understand; subjects like the sterilization of the temporary total artificial heart
(TAH-t) and consumer safety charts and graphs that comply with FDA regulations. When I started my first
day at SynCardia I had 64 tasks to complete, but now I only have 45. Although I've knocked out a little less
than 20 these assignments are extremely long and tedious, however also fairly straight-forward. While
working on this training I have also been asked to complete a few things around the office: one of which was
collecting all the bionumel reports for the auditors coming to SynCarida in upcoming weeks.

Tell me about a specific situation where you contributed or made an

impact at your internship site. *
Although I have only been at my site for three days, I feel as if my presence is very helpful. As of
late, I helped gather all the bioburden reports for auditors coming in-and-out of the following weeks. These
reports tests the sterilization of the heart as well as call for retests (for which these was only one in a two
year period) if the sterilization is higher than FDA allocations will comply to. These procedures are set in
place so that once the heart does go out, there are no alarming failures or strains of bacteria exposed to the
patient. Working with human subjects makes the TAH-t that much more dangerous and needed to be tested
that much more frequently. I like to think that when I put together these reports I took a little bit of the weight
off other Syncardia members, so that they can focus on more important things.

How can you continue to have or increase your impact at your

internship site? *
I have expressed a lot of interest to my mentor in working with the engineers who manufacture the
heart in addition to my duties as an quality intern. As soon as I finish my training and fully understand the
dynamic of SynCardia itself, I will have more time and more clarity when completing tasks. It was said that
this training takes anywhere from one to two weeks and with my 3 hour day schedule I have a feeling that it
might take all month. Following this training, I will be able to donate more of my time and energy into finding
ways to help out around SynCardia. My goal is to eventually seek training in the engineering aspect of the
facility.

Industry Specific Vocabulary *

The most common word, or abbreviation, used at SynCardia, would have to be TAH-t. This acronym
stands for Total Artificial Heart- temporary. While the term TAH (Total Artificial Heart) is used by most
facilities specializing in creating a left ventricle or right ventricle heart, the TAH-t is a more focused term on
people who work with the manufacturing a complete heart, comprised of both left and right ventricles.
Journal Entry 5
Monday, September 26th - Sunday, October 9th

Hours *
18 hours and 45 minutes (18.8 hours)

Two Week Recap *

Fall break has been a time to really dive head-first into my internship. With less school
comes more time to have with my site and my mentor. In these two weeks I've really gotten a
"feel" for the operation. I've gotten to connect with employees and have fulfilled my fair share of
curiosity. Recently I came to the site only to walk right into a paper fight between the cubicles.
Although it seemed a little unfitting for engineers and quality management employees, it showed
me that you need a little light-hearted interactivity to shed daunting and overwhelming tasks like
that of the auditors, who were to survey the area in a number of days. This is just one of the
memorable experiences that make up my time at SynCardia, and I can not wait to start making
more!

Describe a task or set of tasks you are discovering that you enjoy or
excel at completing. Why? *
One of my favorite things to do at my internship site involves working in the lab area.
Although the procedures for going into the clean room facilities are extensive (sanitation,
change of clothes, etc.) the result is extremely exciting. On my recent tour of the facility I got a
chance to look around at the various rooms and stations that are used by the employees of
SynCardia. Even though I enjoy the process, it company makes it very selective regarding who
can and who can't go inside: so I doubt it will happen again for awhile. One tasks I've found that
I'm well-versed in is writing. As an AP English student I pride myself on being able to write
clearly and accurately, a skill which I adamantly bring to my internship site when writing reports
on various research topics that I've conducted. Of these papers I've written, it usually takes
about a day to research and a day to write--two days total. So far, I've written about sterilizing
clean rooms and marking techniques for the heart serial numbers and I'm sure I'll have even
more to write in the near future.

How can you use these tasks in the future, in college, or in a career? *
Writing is a necessary skill in everyday life. Not just one setting. I'm 100% certain that I
will have to write various research papers after my high school career ends, and I'm sure that
will all this writing I will be extremely well-versed in the art of researching. Moreover, I think that
the most important aspect of my internship experience is just that... the experience. I think that
the tasks I've gotten done in the clean room at SynCardia will better prepare me for labs in
college and quite possibly even a career working inside a lab, or lab-like area. I love everything
about my internship from the copious amounts of training to the dressing out to enter the sterile
environment. By accomplishing my daily tasks I'm preparing myself for a future in the
sciences--my ultimate goal.

Industry Specific Vocabulary

Cardiac Output is a formula used by the engineers at SynCardia. The entire formula is
CO=SVxHR where SV stands for Systolic Volume and HR is Heart Rate; the output is measured
in liters per minute. The term was used while undergoing hours of training--you can never be too
careful when working with human subjects. Being in this line of work means that you also have
to be skilled in the mathematics and understand the whys of it all, before really undergoing any
intensive projects.
Journal Entry 6
Monday, October 10th - Sunday, October 23rd

Hours *
6 hours

Two Week Recap *

In these two weeks I had my site visit with Mrs. Wahl. Although I don't generally go into
the area that were on our tour, it was nice to see how my internship site runs as a whole. From
manufacturing to testing we saw it all and we even took a few pictures! The most interesting part
of the whole tour was probably the spus lab, and we even got to see the material in action. It
was really beneficial to sit down at the end of the tour with Mrs. Wahl and think about what I
expected from the internship and what could be done differently too. Some questions even
addressed strengths and weaknesses that I found at my internship. Overall, the experience was
rewarding and I got to really think about my internship in a new light.

Describe a situation in the past few weeks in which you were

frustrated by a task or experience. *
At my internship site, I have several projects to work on during my time there. Most
recently, I was assigned to find a laser for engraving for the SynCardia team to use. After weeks
of research I had typed a report and was ready to get a quote for the machine. Upon emailing
one of the main SynCardia contacts I did not receive an email back for several days. As a
problem-solver, I tried contacting another person and they were communicating with me via
email for a few emails and had attached someone else to the email who might be willing to help
me. After weeks with no return I reached out to this person again and finally got the information I
was looking for.

How did you communicate with your mentor and/or Mrs. Wahl
regarding this frustration? If you did not communicate, how should you
have handled the situation? *
I spoke with my mentor about those who had not responded to my email and he agreed
that I should just wait it out. Yet, as time drew on something did not feel right so I contacted
another. The process took a good two weeks and slowed down my ability to deliver on this
project. After finally getting in touch with the right person who was quick to email me back, I
forwarded the information along to my mentor so the company could make a group decision.
This upcoming Monday, I hope to hear that SynCardia will go through with the system and we
can really "get the all rolling" on this project. In the future, I feel like I should keep my mentor
more informed and be more assertive in the email process.

Industry Specific Vocabulary *

When I first started my internship at SynCardia, auditors were in the wake of touring the
facility. One assignment that I had to complete was filing bioburden reports. Bioburden is almost
exactly what it sounds like and is the "burden" of the biological elements put into the human
heart. This can be seen especially well in the sterilization process.
Journal Entry 7
Monday October 24th - Sunday, November 6th

Hours *
3 hours

Two Week Recap *

Most recently, I had to contact several companies while working on a project for my
mentor. I've never been one to email several people at once and the experience was quite
daunting. All in all, I contacted 6 companies who specialized in engraving materials. I learned
that people respond at different rates. It took one person an hour to reply and another over a
week. Ultimately, I learned that communication is really key and sooner responses are better.

What have you done that you didn't ever think you would be able to do
and how did the experience come about? Did your mentor push you or
did you request the experience? *
When I first started at my internship I told my mentor I was really into the medical aspect
of the artificial heart process. Working in with the quality department of my artifical heart
internship, this is not an easy request. At a recent site visit, we brought up these issues again
and my mentor is currently working on a solution. I requested the experience and I'm glad I did.
Communication is key in any environment, and if you don't speak up, your problems won't be
heard.

How has this experience affected your overall confidence in your

internship and your relationship with your mentor? *
I feel more confident in my relationship with my mentor after this experience. I ultimately
feel that it's important to branch out especially in a system as complex as SynCardia's. I also
feel very confident in my internship as a whole. My ability to experience more than just one
aspect of my internship is key in my understanding of how the company works and functions. So
far, I've seen the manufacturing floor, lab space, and SPUS lab. In the future, I hope to work in
engineering and a hospital setting.
Industry Specific Vocabulary *
Marking System. I had never really heard the term before starting my Syncardia project.
A marking system is a machine that permanently engraves or "marks" its object--in this case, an
aluminum tag.
Journal Entry 8
Monday, November 7th - Sunday, November 20th

Hours *
6 hours

Two Week Recap *

At my internship site recently, I have scanned huge binders of information to be put in
our online database. Although this seems like an easy task, it is pretty daunting after a while.
The hardest part came when I did not have the resources to upload the documents to the
database. After a week I had received the program to upload, however, there was another
problem: I had not yet finished the training to upload the documents correctly. Ultimately, I have
learned that sometimes it takes more than one person to get a job done. You have to
collaborate when more than one person to finish it both swiftly and accurately.

Describe your initial impression of your internship experience. *

When I first arrived at my internship site, it seemed really big. I was worried I would get
lost on my first day. It also seemed really professional and somewhat strict. When I started my
first assignment--MasterControl. I had over 50 tasks to accomplish. I was afraid I would have to
memorize each and every one of them, but fortunately that was not the case. After
understanding the principles behind each document that I had to read through, I understood
more and more about what SynCardia is all about!

Think about the past several months. How has your initial impression
of your internship experience changed over time? *
I still believe that SynCardia is a professional environment and I need to exhibit
professionalism each and every time I enter the premise, but I also realize that they are not the
strict people I once thought them to be. There is lots of laughter and banter whenever I'm there
and I'm positive that the carefree feeling is there after I leave as well. SynCardia is not like any
place I've ever worked before (granted I haven't worked at very many places). The terminology
and lingo of heart manufacturing is advanced and processes are explicitly stated, and everyone
(for the most part) knows it. Collaboration is expected on the daily, and you most likely will not
get through your day without speaking to at least five other people. It is a community at my
internship, and that is one of the reasons I like it so much.

Industry Specific Vocabulary *

 When playing around with MasterControl, the online database system of SynCardia, I
came across a few terms I had never heard before. One of which was Info Card. Info Cards are
fairly simple to explain and the principle is easily understood, the Info Card is a tool that clarifies
what classification the document is under. Ultimately, this helps the information's ability to be
organized in different ways, depending on your search.

.
Journal Entry 9
Monday, November 21st - Sunday, January 15th

Hours *
19.5 hours

Two Week Recap *

The last visit I had to my internship site was nothing short of frantic. Because this was
the first time I visited SynCardia in the New Year, there was more than just a little to accomplish.
I first checked in with my mentor and submitted the last project I had worked on, but soon after it
was non-stop and fast-paced. I submitted documents I had scanned to the online database,
reviewed product quality reports and talked to my mentor about the project I had to submit
towards the end of the year. Although it gets busy at my internship from time to time, I had
never personally felt pressed for time, until this day. Ultimately, I can say I felt more
accomplished leaving my internship site on this day compared to others in addition to feeling
like a bigger part of the team! I am excited and eager to experience more days like this as both
my time at SynCardia and my knowledge about the practice grows.

Does your internship site offer health, vision, and/or dental benefits to
its employees? What benefits do they provide and how does an
employee qualify to receive them? Describe some differences in the
levels/plans offered. *
All full-time employees receive health, vision, and dental benefits. Of these, there are
policies that dictate set vision and dental plans. However, the health plans are more tailored for
each employee. Factors such as family status and deductible is considered when applying for
ones health coverage. This is the only qualifying aspect of SynCardias benefits. Since all
full-time employees receive health care, and a majority of the staff at SynCardia is full-time there
are not any specific obstacles that are addressed when one receives their health care. There
are no additional plans offered to the aforementioned three.

Does your internship site offer pay increases? If so, how are they
decided (time worked there, comission/sales, performance, etc.)? *
As any other job would, my internship site offers pay raises to its employees. Each pay
raise is determined based on three very important factors: performance, time spent, and the
company budget itself. For example, if the SynCardia had extra money left in the annual budget
for an employee with 10+ years under their belt and an amazing turnover rate, then that person
would most likely have a better chance of attainment than, say a newcomer who is slow to
answer questions and barely gets work done. Each situation is hypothetical and can only occur
if the budget is open. Yet, an opening in the budget does not necessarily mean pay raises
all-around. SynCardia has many other expenses to consider, opportunities that could help the
company grow and expand for years to come, such as, but not limited to: machinery updates,
staffing changes, and R&D funding.

Industry Specific Vocabulary *

Engineering protocol - the validation and implementation of a new process in the
SynCardia system, contains three important parts: Installation Qualification (IQ), Operational
Qualification (OQ), and Performance Qualification (PQ). As a part of my final project for the
internship program, it is my job to create an engineering protocol for a piece of machinery that
will soon be integrated into the SynCardia Lab. When I first came across the term, my mentor
pitched the idea of helping me create an engineering protocol to help understand IQ, OQ, and
PQs in the documents I was reading and also continue a job that I had already started.
Journal Entry 10
Monday, January 16th - Sunday, January 29th

Hours *
3.5 hours

Two Week Recap *

At my most recent visit to my internship site, my mentor was not there. Although he had
assigned me work and I knew what needed to be done, I still felt out-of-place. It was then I had
to take on my own responsibilities and find information out on my own without the help of my
mentor. Ultimately, I found that in a professional environment you cannot always be asking
others for help and sometimes need to rely on your abilities as an individual. In my case, I had
researched and computed just what it takes to start writing my final project. By the end of the
day, I felt more accomplished and better prepared for the next time my mentor was off-site.

Industry Specific Vocabulary *

Process validation - the assurance that a process is repeatable through the collection
and evaluation of data. I came across this term when searching on MasterControl, the online
Database of SynCardia. Through my understanding of the term, I am better equipped to
continue my final project as I will need to reference process validations in the objective and
performance qualifications of my engineering protocol.
Journal Entry 11
Monday, January 30th - Sunday, February 12th

Hours *
6.5 hours

Two Week Recap *

These past two weeks I have been working on my final project. While it proves to be a lot
of work, there are definitely some obstacles that I have faced. For example, to access some
documents I need to complete a series of training or to understand what I am accomplishing I
need to go through templates and read summaries of how to write protocols. Several issues
came up while I began my project, more than I initially thought would surface, but as I learned
how to overcome them, time became a bigger and bigger issue. I know that my project will be
completed within the time limitations, but I worry that I will not meet the deadlines I have created
for myself. For example, comprehending the various manufacturing documents that were sent to
me proved to be a struggle, more specifically the diagrams addressing parameters and
minimum clearance for the machinery I am in charge of following. I spend around an hour trying
to decipher the information, but ended up going home empty-handed at the end of the work-day,
it was not until the next session I had at my internship, with fresh eyes that I understood what
the information meant. I now know how lengthy of a process this project is and I am both
anxious and excited to finish.

Describe in detail a project or task where you collaborated with your

mentor or co-workers *
Over winter, I had the opportunity to meet the other intern at my site. While my mentor
was on vacation, I had the opportunity to work with various employees around my building, but I
helped the most with this other intern. She had a project assigned to her where she had to
summarize the faulty artificial hearts claims from the Freedom Driver--the most portable of all
the devices. We worked in two different excel spreadsheets to combine our work later. There
were over 1,500 claims to summarize, so the task was no easy feat. The project only lasted
about three days, with our combined efforts, but could have been a lot longer if we were working
solo.

What did you enjoy about working together? What was difficult about
collaborating? *
I enjoyed branching out from just collaborating with my mentor, and I felt a better sense
of well-rounding after the project was complete. Although I am an intern for the quality
department, branching out to engineering was an exciting change or scenery. The only difficult
part about collaborating was the fact that we could not share one document. The constant
updating of the documents we were working on was more annoying than difficult, and the fact
that our schedules differed made it harder to ask questions and verify information on the
document. I also felt a sense of urgency attached to this project, and a majority of the
summaries I read were rushed, but I still double checked my results when the work was
finished. Overall, I am grateful for experiencing a group-project at my site, and it give me new
insight into what it is like to have a career in quality engineering.

Industry Specific Vocabulary *

Pin-Marking System--a device that makes indentations on metal/plastic/etc., allowing to
engrave letters, numbers, and symbols to smaller pieces of material. I was introduced to this
term around October, when I started a project to find a pin-marking system that was not only
cost-efficient, but also fit the needs of the site. The term became important again when I started
the protocol for installing it as apart of my final project.
Journal Entry 12
Monday, February 13th - Sunday, February 26th

Hours *
9 hours

Two Week Recap *

This week at my internship site, the project I was working on was too costly and a
cheaper alternative was found. This also means that I had to abandon all the work that I had
previously done on the project. It was disappointing to say the least, but I recovered quickly.
Everyone at my internship site was amazing in the transition and my mentor even found me a
new project to work on with a similar objective so I wouldnt be too confused. The next time I
visit my internship site, I will have a new project to work on and I am excited to begin the
process again. This opportunity only goes to show that things do not necessarily work out the
way you expect in a business setting; things are always rapidly changing and if you cannot keep
up, you will never last.

Industry Specific Vocabulary *

Shop Order - the purchase or desire to purchase a new piece of equipment. I was
introduced to this term when I had to file multiple shop orders after I had completed an
assignment. The shop order itself is roughly 5 pages long and documentation for every new part
is critical in the SynCardia process.