1.

Describe your experience with embedded systems and safety critical systems

Answer: I do not have any experience with Embedded system. I have experience with a
safety-critical system, which is described as following:
Surgical Stapler is an electro-mechanical surgical instrument used in minimally invasive
surgeries to dissect and staple tissues simultaneously. The cut and staple nature of the device
has one hyper-critical failure mode whereby surgeons may pull the “firing trigger” to actuate the
knife without the presence of a cartridge. When this happens, surgeon will cut the tissue
without deploying any staples and thereby causing perfuse bleeding and potential loss of life.
The “lockout” mechanism is designed to ensure that when a staple cartridge is not placed into
the surgical stapler, the knife is “locked” in place and unable to be actuated to cut into soft
tissues. This is the safety critical mechanism that must be designed, optimized and verified to
perform at no more than 3.4 deflects per million.
I created a mathematical model that allowed the team to correlate 58 different input variables
(feature dimensions) to the performance of lockout both deterministically as a quantitative value
(engagement depth) and probabilistically as a defect rate (over a PDF)

2.Describe your experience in authoring or development of systems engineering product

such as: requirements, system architecture, and system verification and validation.

a. What was your role?

Answer: I have two roles, one work as component engineers, designing components based
upon previously cascaded sub-system and component level requirements. I design
components on CAD, create drawings per ASME Y14.5 2009 GD&T guidelines, discuss with
suppliers on optimization of design per respective manufacturing techniques (usually Injection
molded parts, MiMed parts and sometime machined parts), develop tooling and then verify the
component meet sub-system requirements via bench marking testing before finalizing design
specification.
Second, I work as system engineers creating transfer functions between component level
dimensions to system level functions. The previously mentioned mathematical model is
composed with 7 different sets of transfer functions which characterizes the system.
System level model allow optimization of the entire system and allow multiple component
engineers to collaborate effectively without making changes with interaction that may confound
the problems.

b.(For one of them) What type of technical challenges did you face?

Answer: The greatest challenge was developing the model. I will describe challenges in
itemized fashion below
1) After many attempts to find a “golden bullet” factor in the variation of lockout
performance (by doing Red-X, component swaps, and other experiments), there’s
 clearly not a single factor and therefore, it’s very likely there are either 2-factor or 3-
factor interactions that are significant in the behavior of lockout. How do I find what they
are, how can I divide a complex system and cascade it down into more manageable
sub-systems to better control variation and optimize the system.
2) How would I create a technique that allow me to account for both linear Tolerance Stack-
up Analysis and the deflection of these components associated with energy transferred
from the handle portion of the device (either via hand actuation or motor actuation).
3) We did not have a gauge to actually measure lockout performance as variable data so
it’s always a pass/fail type of assessment which required a large number of devices or
sub-assembly to be built to be able to assess even the smallest changes. This makes
making trials and errors very difficult because it’s too expensive. This also makes
analytical approach very appealing.
4) Lastly, the mechanism was designed to perform adequately when prototypes, but how
do we make sure it performs at six sigma level (3.4 defects per million) when the initial
observation was a 2 percent defect (built 300 pieces)

c.What type of challenges did you face with stakeholders? Describe your approach.
Answer:
StakeHolders in my case are
a) R&D Director – we have timelines to meet and lockout is becoming a critical path issue
b) Production Line – they need to know how to minimize scrap and they need a way to
measure lockout either as variable data or attribute data.
c) Marketing – same as R&D
d) Quality / Regulatory – initial requirement work book has clearly indicated performance
level of lockout (CTQ and therefore defined as 3.4 defects per million)
The challenge here is, we have a non-robust lockout design (sensitive to variation at component
level), we have limited time and we need to meet the highest quality requirements. The
solution here is what I believe to be the best approach – we need to have a holistic view on the
problem and create a solution that allow us to predict the impact of multiple changes at the
same time.
For example, the system has 45 components, we may need to change 5-7 components. We do
not want to change 1 at a time and build 300 devices just to assess its individual impact, we
need to make 300 devices with all 7 changes and evaluate all 7 as a combination. This
drastically improves our efficiency and is honestly the only way we can make everyone happy.

3.Why would you like to work at Bigfoot Biomedical?

Answer: I have 3 parameters in my current job search, in descending preference
1) I need some stability. I honestly don’t want to look for work again if possible. An
organization that is stable is one that values organization and structure so that everyone
on the team can work effectively to get things done. This is so critical to stability
because we have to get a lot of things done to not only earn our paycheck, but to create
 enough value for the company to succeed. If the company fails or do not do well, we are
all screwed.

2) I want to work in an environment that values doing work that we all feel proud of.
Whether or not you believe in my ability, it does not diminish how proud I feel about
some of the work I’ve done because I poured my heart and soul into them. My model for
lockout is one of my few examples.

An example of work I am not proud of is one in which I am asking to lead design history
file efforts without support from a cross management team. We created a situation in
which we generated 100+ documents and had less than 10 documents signed off.

3) As a Hope (least important of my 3 parameters), I want to work with a group of people

truly doing amazing work in their field and trying to do things that’s not just a cheaper
version of something that’s already out there. It honestly feels terrible when my design
input reads “make something just like the one Medtronic has”.

4.Are you eligible/authorized to work in the U.S?

Answer: Yes, I am a US permanent resident.