Medical Device

AKSHAY KUMAR APPAVOO SUKUMAR

M.S. Biomedical Engineering

§ ************@*****.*** \ 206-***-**** https://www.linkedin.com/in/akshay-kumar-appavoo-sukumar/

SUMMARY OF QUALIFICATIONS

Proficient in Medical device innovation and development especially translating clinical needs to commercially viable products with an extensive background in Biodesign.

Adept in the regulatory approval pathways for medical devices and the governing FDA, eCFR and ISO guidelines.

Qualified in Lean Six sigma foundations for Medical device development process improvement.

•Skilled in advanced technical writing gaining experience in the

SKILLS

RAPID PROTOTYPING

CAD & FEA

documentation for Patent application, NSA and SBIR grants.

Proficient in product commercialization strategies such as business need analysis, market analysis, economic impact analysis and IP protection.

Efficient in collaborating with stakeholders to identify and develop potentially disruptive medical devices and technologies.

PROFESSIONAL EXPERIENCE

R&D Intern (Health-tech Innovation Center)

Access Health care Physicians LLC.

Oct 2017 – Present @ Tampa, FL

Responsible for the product ideation and the concept development for potentially disruptive implants and prostheses for orthopedic applications

Highlights Responsible for User needs generation and screening facilitated by clinical observations of surgeries and clinics.

Strong emphasis on New product development processes involving market opportunity analysis, patent landscaping and proof-of-concept development.

R&D Intern (Interventional Cardiology)

University of Washington Medical Center

June 2017 – Nov 2017 @ Seattle, WA

Developed a novel guide extension catheter used in percutaneous intervention procedures that offers increased mobility and durability, in collaboration with an interventional cardiologist at UWMC

Highlights

•Performed GD&T and Stack Up analysis for the development of a

TECHNICAL WRITING

QUALITY CONTROL

DATA PROCESSING AND MANAGEMENT

EDUCATION

Master of Applied Bioengineering

University of Washington

Aug’16 – Aug’17 @ Seattle, WA

Coursework

Biodesign skills: Syllabus comprised the understanding novel medical device design needs, needs filtering, proof of concept generation, prototyping, Design implementation strategy and planning.

Data visualization and CAD: Syllabus comprised the understanding of Projections, Parametric solid modeling, and GD&T with a strong focus in CAD using Solid works.

GPA: 3.5/4.00

functional prototype for an origami based interventional catheter.

Responsible for the quality system regulation analyses and documentation required for the 510k submission.

Product development engineer

UW Dept of Bioengineering

Aug 2016 - May 2017 @ Seattle, WA

Developed a novel percutaneous ablation catheter with improved mobility and flexibility, to remove atherosclerotic plaques in the cardiovascular system, under the guidance of Prof. Molly Blank at UW

Highlights

Bachelors in Biomedical Engineering

PSG College of Technology

Jul’11 – Jun’15 @ Coimbatore, India

Coursework Anatomy and Physiology • Pathology and Microbiology • Biomaterials • Biomechanics

•Artificial organs • Cell Biology and Tissue engineering • Biosensors and transducers • Biomedical Equipments • C/C++

GPA: 3.94 (WES Evaluation)

Performed a Waterfall design analysis to manage the Design history

file, and risk management analysis using FMEA.

SKILLS

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