Electrical Engineer Medical Device

beejal mistry

**** **** **

Vancouver, BC Tel:778-***-**** aborq3@r.postjobfree.com

engineerING & managerial professional

Electrical/Medical Device Engineer with over 10 years experience in a variety of industries and expertise in creating innovative designs, simulation, prototyping, test and high volume manufacturing. Strong background in product life cycle and failure analysis of medical devices and electronics. Extensive sales support experience including on site customer training.

technical skills

FDA13485

Test fixtures/Protocols

5S ISO9001 PCB design (multi-layer)

UL/CSA/TUV Standards

PROFESSIONAL EXPERIENCE

engineering consultant 2010-PresentClients include Water quality systems, Medical Device & Generator fault analysis

APPLIED MEDICAL, rsm 2009-2010

(Medical Device Company) Electrical Engineer

Created test fixtures and test documentation for next generation productsCompleted prototype PCB designs for proof of conceptWorked closely with electrical device contractor to facilitate new test concepts

henkel corporation, irvine 2007-2009

(Global Electronic Materials Company) Applications Test Engineer

Responsible for design, development and fabrication of specialized test equipment & test capabilities that allowed for faster turnaround time and quicker product launchDesigned PCBs to perform electrical test on materials (under-fill, potting and packaging material) - capability that propelled Henkel ahead of competitorsPerformed reliability analysis of data generated from test systems. Test system examples include data log circuitry to monitor resistance, voltage and current delta over time when exposed to harsh environmental conditions. Systems incorporated redundant safety features and passed audits easilyUpdated colleagues regarding the status and progress of engineering projects using PowerPoint with text and graphics to emphasize key pointsCreated standardization features in designs that allowed for up to 10x reduction in test timeDeveloped engineering reports to summarize data, indicate trends or behavioral changes in tested materials

interface associates, laguna niguel 2005-2007

(Medical Device Company specializing in angioplasty technologies)

Electrical Engineer & Dept Manager

Managed Test Dept for various medical catheter-manufacturing machines and introduced streamline methods that reduced validation times by up to 50%Performed complete system level validation & functionality tests Created calibration database that helped to insure all equipment was IN-CAL per FDA guidelines Introduced documentation procedures that resulted in ISO/FDA re-certification

IMI-USA (FORMERLY saturn electronics), tustin 2004-2005

(R&D Company) Test & Process Development Engineer

Responsible for developing processes and test procedures for prototyping and volume production of electronic assemblies Created functional electrical tests involving SMT, wire bond and flip-chip technologies Generated test plans & test documentation resulting in easier operator use and increased efficiencyDebugged circuits down to the board level using such means as: Checking for opens & shorts using a DMMImplementing use of oscilloscopes to verify correct waveforms at specific nodes

contract/temporary assignments 2002-2003

cadence/tality, san diego 2000-2001

(Global Software Applications Company) Electrical Engineer

Responsible for verification, validation and testing of mixed signal integrated circuits (ASIC’s)Worked on Automated Test Equipment (ATE) to characterize new IC designs

pulse, san diego 1997-1999

(Components and Electronic assemblies manufacturer) Electrical Engineer

Responsible for design, development, prototyping and high volume production of transformers and filters (magnetics)Created transformer design on-time and under budget that exceeded customer specifications resulting in a $100K contractSupervised technicians through guidance and creation of manuals/test documentation that empowered them to become more independent and competent

EDUCATION

BSEE, Queens University, Kingston, ON

Thesis Project: Designed and built a biomedical engineering device that measures and monitors the pupil diameter of the human eye as it varies with light intensity. Incorporated the use of infrared emitter/sensor technologies

EXPERIENCE, knowledge & certifications

C++&ASSEMBLY

High&Low Voltage design

PCB layout tools: Altium & CAD/Pentalogix Writing technical manuals & final reports

Able to train and mentor co-workers Producing BOM’s & ECN’s

Familiar with most bench-top equipment

EXPERIENCE GAINED FROM WORK RELATED PROJECTS:

APPLIED MEDICAL

During my tenure at Applied Medical, I was responsible for modifying/creating electrical designs for a plug-in tool that was controlled by a proto-type ESG (Electro-Surgical Generator). The entire ESG was subcontracted out to a 3rd party vendor; however, I was responsible for the development of a dissecting tool. I realized after reviewing the schematic, that there were no test points on the PCB or on any of the interconnects. I went ahead and made a few changes to introduce probe points to allow for more test coverage during assembly, and therefore catch any defects before final assembly. I also created a custom testing black box, that mimicked any plug-in tool to allow testing of prototypes easily when that tool was inserted into the ESG.

I took the initiative to contact the ESG contractor and peripheral PCB suppliers so that I could gain insight into the workings of the entire system.

This role was a great learning experience for me as an engineer as it allowed me to delve into creating actual surgical tools and testing those tools on a live animal study. I learned that data taken on tissue samples vs. on live organs were vastly different – and performance on competitor tools vs. Applied Medical was quite significant. An example of this phenomenon was measuring burst pressure on a seal created on a blood vessel. The competitor tool outperformed the Applied prototype. This gave me insight on the electrical characteristics of a particular sealing tool where surface area and pressure applied at the seal site had a vast impact on the integrity of the seal generated (this is for a given fixed current and voltage).

HENKEL

I was asked to come up with a HAST test (Highly Accelerated Stress Test) for a new mold compound being developed by Henkel. My charter was to create an electrical test including all fixtures, inter-connects and power supplies. I went ahead and researched the test protocol as documented under IPC standards. After I researched the requirements for power, temperature, etc, I began requesting quotes from equipment vendors such as Agilent and Keithley. I placed an order for the power supply (which had an 8-week lead time) and then began designing my fixture taking into account that the materials I selected had to withstand a temperature of 85 C for 168 hours. Selection of a fixture vendor was completed after phone and face-to-face consultations. I was adamant with this vendor that the fixture be delivered on or before the day the power supply was to arrive to avoid further delays.

After all the fixturing and equipment orders were placed, I went ahead and incorporated safety features to this system to avoid or minimize injury to technicians who would take over testing of parts. I organized a training session with the technicians and I also created a manual and had all participates sign off that they were now trained and certified to operate this equipment. My manager was very pleased with my efforts. I subsequently created other test systems that involved the use of data-logging equipment and environmental chambers. I feel my experience at Henkel exposed me to a vast array of new equipment and given me the ability to solve problems in high-pressure time restricted situations.

INTERFACE ASSOCIATES

At Interface Associates (IA), I became very familiar with all the regulatory requirements for the medical device industry (this includes FDA certification). My responsibilities included maintaining the calibration program and database for all the equipment used to build and test the machines made by IA. I insured that all our equipment was in calibration per ISO13485 requirements [my dept passed ISO audit without a single infraction]. It was at my insistence to my direct manager that IA employees become trained and certified in 13485 [all management level employees including myself sat through a 3-day training class for this certification].

I made an impact in reducing test time for all the machines that passed through the Test Dept, which I was in charge of. I worked with the design engineers to figure out ways to create test protocols for various in-assembly stages to help weed out failures before the machine was 100% completed. This reduced any debug time because a failure was caught earlier in the assembly chain.

In this role, I also mentored and taught test techniques to the technicians that worked in my group. But learning was a two-way street as they taught me things about how to make a particular validation process less time consuming without sacrificing test coverage for example.

PULSE

During my tenure at Pulse, I gained valuable insight on what was involved in creating an electrical product. At first, I used my knowledge from university to create designs and simulations of the transformers and analog filters that a customer requested. After creating a design that I felt met the specifications, I went ahead and built a few prototypes and tested them in the lab with various bench top testers such as a network analyzer and DMM. I realized that very rarely did the initial prototype meet the requirements.

There were parasitics that the simulation software didn’t always account for. This was an iterative process where I would make adjustments to the design and prototype. Once I felt I had a design that was sufficient (with data collected), I would schedule a design review with fellow engineers [this team would include process, material, mechanical and quality engineers]. The team would breakdown my design for manufacturability and mass production. I was given suggestions on where the design needed to be changed to make it more robust and less costly to manufacture. With these inputs, I went back and created a new revision of my design and verified it with data taken from a few prototypes. Then I would call a final design review with the same team members and if they felt the design was robust, they would sign off of the design. At that point I would have manufacturing produce a DVT run of this product that would go through all the reliability and quality testing required to insure the product was safe and statistically reliable.

This experience helped me in all my future engineering positions, as I was able to anticipate design issues that were not electrical in nature. Also, I learned that sometimes a customer would present a specification document that was unrealistic (e.g. Transformer winding resistance was too low for the footprint they wanted, Total Harmonic Distortion limit was unachievable at extreme temperatures, etc). In cases such as this, I would present data and documentation on prototypes and present them to the engineering team and program management for review. Management would then request a revised specification sheet from the customer with limits that Pulse could produce ~ and more often than not, it was granted.

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