I am currently an engineer with experience developing products in the medical device industry. I have a passion for innovation and am looking to pivot towards the strategy side of medtech. I hope to apply my knowledge of the innerworkings of product development in a highly regulated industry as well as my purpose for advancing patient care into a position where I can create value for patients, clinicians, and the business.

Bachelor of Science in Mechanical Engineering
Minor in Engineering Design, Focus in Global Health Technologies
Involvement: Student Government (Class Rep, Alumni Relations), Peer Academic Advising lead, SWE, ASME, Intramural Sports (captain)

Rice University

Senior R&D Engineer – Infusion Preparation & Delivery – 
Lead R&D team from Design Inputs through 510(k) submission in development project for IV infusion sets (24 SKUs, $46M)
o Provide technical mentorship and lead execution of design verification (test method development, DV planning/testing/analysis, risk management) and design validation (user experience and human factors evaluation).
o Represent R&D in cross-functional forums and collaborate across 5 interdependent projects to drive efficient impact. • Lead R&D team for euMDR compliance program for 21 Alaris IV infusion sets
o Strategically plan and execute design verification activities to minimize rework, maintain quality, and enable a successful MDR submission. Collaborate cross-functionally, working closely with Quality, Regulatory, and Clinical functions.

Senior R&D Engineer

R&D Engineer II – Engineering Development Program (EDP) July 2019 —June 2022 A leadership development program with three 1-year rotations in unique R&D roles, aimed at developing engineering/leadership talent 

First Rotation: Surgery, V. Mueller R&D– Vernon Hills, IL
• Technical Lead for new product development project for creation of 5 new laparoscopic tool jaw patterns.
• Led V&V testing efforts – created 4 test methods for feasibility/DV testing, including fixture development & Instron programming 

Second Rotation: Urology Home Care R&D – Covington, GA
• Project manager for 2 early-stage innovation projects addressing novel solutions to urinary incontinence in non-acute care setting
• Led projects from unmet need/conception to development by coordinating marketing and R&D efforts in early stage VOC and tech
development work; managed budget, schedule, and resources, including 5 associates and three 3rd party firms
• Maintained customer centricity by generating user/stakeholder requirements from VOC data, following Stanford Biodesign format
• Submitted 30+ Invention Disclosures and filed 13 provisional patent applications

Third Rotation: Vascular Access R&D - Peripheral IV Catheters – Sandy, UT
• Iterated IV catheter design to achieve design freeze under accelerated timeline by CAD modeling, prototyping, feasibility testing, first principles modeling, analyzing, and optimizing. Utilized SolidWorks, DFSS, 3D printing, MiniTab, Crystal Ball, etc.
• Filed 11 patent apps; developed and validated 3 novel test methods; managed risk register, V&V planning, first principles modeling

Serena Agrawal

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