SUMMARY:

• Seeking a position in the field of bioengineering or biotechnology with the hopes of applying my knowledge of human physiology, body mechanics, bio instrumentation, and FDA classification to design, test, and implement medical instruments or manage medical documentation for a hospital, clinical, or rehabilitation setting in efforts to improve quality of Confidential t care.
• FMEA, Root Cause Analysis, CAPA, Medical Device QA, Six Sigma, ELISA, Microscale Devices, Technical Writing, 21CFR, 510(k) Device Classification, Product Required Definition, Product Test Protocols, Team Management, Interpersonal Skills, Microsoft Office, Attention to Detail, CAPA, GMP, ISO 9001 and 13485, Geometric Tolerancing and Dimensioning, Functional Relationship Analyses.

TECHNICAL SKILLS:

Computer Related Skillsets: C++, MATLAB, Javascript, HTML, CSS, Excel, PowerPoint, Office, LabVIEW, Solidworks, Arduino, Statistical Analysis for Quality Control, JDEdwards Applications:

PROFESSIONAL EXPERIENCE:

Confidential

Development Engineer

Responsibilities:

• Responsible for verifying product functionality in terms of mating relationships between Legacy Biomet implants and instruments that engage with Biomet products.
• Utilize geometric dimensioning and tolerancing to mathematically confirm product components geometrically engage with their recipients via clearance, interference, or thread engagement.
• Responsible for writing up geometric evaluation protocols that outline each mating relationship between a product component and it's recipient. Each mating relationship is referred to as an interface. Each part involved in an interface needs to be taken at worst - case, which involves maximizing or minimizing dimensions relevant to that interface in order to minimize successful mating of the parts. Parts are taken at worst-case to show that even when associated parts are in their worst-condition after being manufactured, they will still work as intended.
• Responsible for writing functional relationship analysis (FRAs) which serve as an in-depth, mathematical analysis of how product component clears or interferes with its recipient.
• Work with CAD designers to develop dimensional layouts, which are essentially 2-D prints showing geometric engagement between two or more parts.
• Responsible for adhering to the principles of 21CFR 820.3 - Design Controls as well as Good Documentation Practices.
• Actively collaborate with design input team on design input statements associated with geometric evaluation.
• Utilize Microsoft Office, Sharepoint, and Excel to track implant or instrument interactions that need to be geometrically evaluated, as well as performing link-ups between verification reports and design inputs associated with that report.
• Discuss with technical and team leads on best approaches to handle product interfaces.
• Work with quality engineers to confirm reports that have been written up comply with Confidential and FDA standards for documentation.

Confidential

Intern

Responsibilities:

• Apply knowledge on 21 CFR 820.3 (Design Control Regulation) and ISO 14971 to various projects assigned to me and an additional graduate.
• Projects consist of mock medical devices in use for a specific demographic and setting; based on design specifications, regulatory guidelines upheld by the FDA and the hypothetical company, and project timeframe, it is our job to perform risk analysis and assess quality of overall device design and risk management system as well as make judgements on QMS the company has established.
• Perform design and process verification/validation and write-up related documentation detailing the procedure and results of these assessments.

Confidential

Senior Design

Responsibilities:

• Collaborated with a three-person team to develop a cooling system that would alleviate heat buildup and sweat aggregation.
• Designed a cooling system comprised of a urethane rubber base, in which a network of PVC vinyl tubing was embedded to channel ice-chilled water and allow heat exchange between Confidential t back area.
• Developed a prototype and presented at Confidential competition; prototype was donated to a family at the Easter Seals Rehabilitation Center in Villa Park, IL.
• Assessed optimum flow rate and pad materials using flow and heat simulations

Confidential

Image Editor

Responsibilities:

• Developed 3D representations of various skeletal features or other organ systems as well as edited preexisting images using 3D Studio Max software.
• 3D designs were then utilized by simulation devices to allow medical residents as well as surgeons to perform simulated surgeries (using augmented reality technology) on various parts of the human body
• Worked on over 10 image case files of various anatomical parts such as the spine, hip, spinal cord, and liver

Confidential

Research Assistant

Responsibilities:

• Utilize the Optotrack Certus Position Sensor developed by Northern Digital Inc. to analyze translational and rotational movement of rigid bodies in Euclidean space.
• Analysis is performed using MATLAB; movement profiles are made to understand how a Confidential t is able to walk post-surgical implantation of medical implants, primarily around the hip and knee regions.