Dillan Nayee Email & Phone Number

Bedford, Massachusetts, United States

• Review and approve CAPAs, Change Controls. Manage Internal and External Auditprograms and maintain associated tracking logs within the Electronic Quality Management system upon implementation.
• Evaluates and improve the above programs to ensure compliance with regulatoryrequirements.
• Performs internal audits as assigned and track implementation of audits observations foron time closure.
• Leads investigations, performs root cause analysis, prepares detailed investigation reportsand implements corrective actions as needed.
• Performs QA review of new and revised procedures, technical protocols, validations andreports as assigned.
• Participates as assigned in the development of customer requirements and design inputs;works with team to ensure that customer requirements (user needs) can be validated anddesign requirements can be verified

Fishers, Indiana, United States

• Communicated with technical service, quality, engineering, and management teams to perform root cause investigations in visual inspection and insulin processing areas
• Presented findings to cross-functional subject matter experts and assigned corrective and preventive actions (CAPAs) to eliminate the root causes of issues and prevent recurrence
• Owned changes and ensured implementation occurred in adherence with standard operating procedures, as well as quality and regulatory requirements
• Developed proficiency in Trackwise, Veeva QualityDocs, and GMARS electronic document management systems

-Medical device patent drafting and prior art research.-Medical device documentation (DFMEA, Validation Protocol) and associated testing. -Product conceptualization and computer-aided design (Autodesk Fusion 360, AutoCAD)-Prototype design, creation, and testing -CNC machine experience-Medical-grade plastics RF welding and thermoforming processes-Technician.

Indiana

-Chief Design Officer 2015-2019-Co-founded company in the fall of 2015-2nd place winner of 2016 Big Sell Entrepreneurship Competition -Developed and designed innovative, highly compact bag valve mask for outpatient use by certified personnel. Created CAD images of potential ideas along the way. Utilized engineering and critical analysis skills as well as.

West Lafayette, IN

- Assisting in development of self clearing catheter micro device- Responsible for evaluation of magnetic properties of microactuator- Developing a model of relationship between size of microdevice, impending current, and resulting deflection angle-Developing innovative table tilt mechanism for large inductor to be used during surgical placement of.

Rancho Santa Margarita, CA

-Investigated and evaluated electronic-based surgical device assembly process and implemented associated improvements-Organized and ran meetings to update team regarding project progress.-Wrote validation and qualification reports related to testing fixtures for medical device-Performed root cause analysis on failed medical device units to identify errors.

Warsaw, Indiana

-Developing an understanding of knee replacement surgical technique and surgeon preference for instruments.-Experience with cadaveric surgeries for verification and validation of knee replacement surgical instruments and implants-Learning about industry testing methodologies, and related anatomy, pathologies, and surgical procedures-Utilizing CAD tools.

Fishers, Indiana

Responsible for tutoring young students aged 7 - 14 in math and reading subjects. Communicated any difficulty with teaching or progress of student with parents.

Fishers, Indiana

Responsible for caring for sick small animal patients by medicating, feeding, and walking. Recorded any specific medical instruction and ensured medication was administered. Reported any severe problems and/or emergency situations to veterinarian on call.

Bachelor'S Degree, Biomedical/Medical Engineering

International Baccalaureate

Activities and Societies: • Model United Nations • Robotics Team Co-Founder • Student Government Representative • National Honor Society