Kishan ********

CAREER PROFILE

Multi-talented and ambitious Mechanical Engineer with combined 3+ years of proven experience in New Product Design & Development for R&D labs & contract manufacturers. Leveraged certified 3D CAD, R&D, FEA, manufacturing & regulation expertise by leading cross-functional teams to deliver proven high-quality engineering solutions & Class II FDA devices

 

EDUCATION

Master of Science in Mechanical Engineering | Purdue University August 2018 – May 2020

 

SKILLS AND CERTIFICATIONS

● Software: SolidWorks, MATLAB & Simulink, Ansys, Abaqus, Fusion 360, Inventor, AutoCAD

● Languages: Python, C, C++, Java, CNC (G Code), Markdown

● Engineering: CAD, CAM, FEA, FMEA, SPC, Geometric Dimensioning, T olerance Analysis, Product Design, 3D Printing,

Engineering Drawing, Materials T esting, Biocompatibility T esting, Optics Design, Project Management

● Quality: FDA Compliance, Class II, 510(k), QMS, Design Controls, Verification and Validation (V&V), Clinical Study,

ISO 14971, ISO 13485, ISO 10993

● Certifications: Certified SolidWorks Professional – Advanced Surfacing (ID C-AXWBND2U96)

Certified SolidWorks Professional (ID C-3TSCZQHVMF)

Autodesk CAD/CAM/CAE for Mechanical Engineering Specialization (ID 894GU5QGWSNN)

Autodesk Generative Design for Additive Manufacturing (ID PHJYE7EMYWA9)

Autodesk Generative Design for Industrial Applications (ID AQAQ4EJFF9RR)

Autodesk Generative Design for Performance and Weight Reduction (ID 8Z4FEGPMCHDZ)

CAM and Design Manufacturing for Mechanical Engineers with Autodesk Fusion 360 (ID

5G8A4MUCAMAH)

Mechanical Engineering Design and Manufacturing with Fusion 360 (ID 62JPLAA7KTMR)

Modeling and Design for Mechanical Engineers with Autodesk Fusion 360 (ID FKPG5KJNK9TM)

Simulation Analysis for Mechanical Engineers with Autodesk Fusion 360 (ID BFN2WSJBWC8U)

IBM Deep Learning & Neural Networks with Keras (ID HPLEPBQ7DXN8)

IBM Machine Learning with Python (ID X7VHF5K7ENSP)

 

EXPERIENCE

Lead Project Engineer, Product Design Engineer | NIRSense (formerly Bionica Labs) August 2022 – Present

● Developed QMS documentation in accordance with FDA regulations

● Coordinated successful testing to various international standards – such as IEC 60601-1, ISO 10993, IEC 60529

●  Led opto-mechanical design of 3 compact, wearable systems involving lensing & focusing components, & PCBs

● Led the design & testing of 4 generations of prototype proof-of-concept devices for novel NIR spectroscopy applications

● Led the conceptualization, prototype development and electrode design evolution of 3 generations of a novel ruggedized

multimodal device integration fNIRS, ECG, temperature and ambient pressure sensors

● Worked with electrical engineers to integrate PCB components with body conforming flexible & rigid enclosure designs

● Using optical & structural analysis techniques, optimized the optical response of flagship NIRs monitoring device by

designing & prototyping >10 fixtures & vacuum molding the family of optically clear lenses in-house

● Spearheaded the development of a detailed Trace Matrix to track all Design Controls per FDA guidance, resulting in

reduction of multiple design and project risk indices per QMS

● Checked manufactured parts for accuracy to design intent, engineering tolerances, and conformance to quality standards

● Generated engineering drawings and production documents for critical mechanical components of of flagship NIRs device

● Followed best practices for design controls & QMSes including version control, configuration management

● Coordinated prototyping activities between NIRSense team & external manufacturing, material supply, & vendors

● Vetted domestic & international manufacturing sources for NIRSense systems with a focus on scale & commercialization

 

 

Mechanical Engineer | Inteprod LLC July 2021 – August 2022

● Saved >$100k in production costs by designing 30+ plastic injection molded components for a handheld medical device

● Saved >$20k by conducting 400+ experimental trials using DOE principles to identify root cause of thermistor failure

● Achieved 100% yield rate & reduced assembly time by >50% by designing & implementing new 3D printed fixtures

● Reduced failure rate from 50% to 0% by identifying root cause of acoustical dysfunction via sound-chamber testing,

proposing & implementing a cost effective and easy-to-manufacture solution, saving >$70k in manufacturing costs

● Owned & led successful FDA 510(k) submission filing of audit-compliant Design History File (DHF) for 3 major projects

● Authored IEC 61010-1, ISO 14971 & ISO 13485 compliant Product Requirements Documents with ME specifications

● Authored >100 Design Specifications, Risk Management & Controls for EU MDR & 21 CFR Part 820 compliant device

● Oversaw knowledge transfer to & training of 3 assembly personnel based on authored work instructions with no failures

● Improved device robustness by designing a sheet metal housing for EMI shielding from near & far field radiation

● As Project Lead, delivered high quality presentations showcasing designs & experiments to update clients & partners

Mechanical Design Engineer and Quality Engineer | Air T o All February 2021 – July 2021

● Created airtight pathway by executing CAD design & DFMA of 10 plastic injection molded parts of PAPR in SolidWorks

● Reduced risk indices of 20+ components by leading DFMEA & root-cause analysis sessions with cross-functional teams

● Authored & documented 50+ Verification & Validation (V&V) tests using NIOSH standards for new product development

● Facilitated production of 20+ parts by preparing engineering documentation, reports & drawings based on ASME Y14.5

● Interfaced with component suppliers to coordinate internal first article inspection of 5 parts on function, quality & cost

● Managed creation & update of documentation & engineering change requests (ECRs) of 10+ parts per control procedure

● Consolidated inputs from 10+ customer, marketing & external consultants to improve product & detailed requirements

● Expedited product development timeline by 5 months by streamlining, documenting & publishing all action items.

Mechanical Design Engineer | RespiraWorks December 2020 – March 2021

● Designed 3 secure housing frames in 3D CAD using Inventor & performed structural analyses to model failure using FEA

● Developed cheap & robust prototype mounting solution for pneumatics by designing 3 acrylic trays in Inventor

● Integrated 6-layer PCB stack, electronics & display assembly by modeling in Inventor using tolerance stack analysis

● Automated & implemented BoM solution & instituted organization-wide ISO standard templates for 2D drawingsGraduate T eaching Assistant | Purdue University August 2019 – December 2019

● Instructed graduate course – Design for Manufacturability including 5 hands-on lab sessions on machining & fabrication

● Tutored 60 students on GD&T, DFA, tolerance & fault-tree analysis, FMEA, DOE, SPC & redesigning consumer products

 

 

Graduate Research Assistant | Purdue University August 2018 – May 2019

● Applied solid mechanics to study response of Mode I & II cracks in Polymer Bonded Explosives via FEA simulations

● Developed continuum phase-field model in C++ to calculate stresses and strains using MATLAB for data visualization