SHAWN S I NBELA

***** ****** ***** ** *****, Florida, 33328 954-***-**** actdr7@r.postjobfree.com

W O R K E X P E R I E N C E

STRYKER (MAKO), FORT LAUDERDALE, FL

Product Development Engineer, May 2013 – Jan 2016

Developed orthopedic implants and instruments using a phase gate design control process and extensive documentation of development and testing

Designed robot integrated surgical instruments for the implantation of orthopedic implants using Solid Works and Pro-Engineer Creo

Produced, read and interpreted technical drawings for implants, instruments, and trays using knowledge of Geometric Dimensioning and Tolerance (GD&T)

Conducted research to analyze the feasibility, design, operation, and performance of equipment, components, or systems. Includes failure mode and risk analysis.

Developed and tested models of alternate designs and manufacturing methods to assess feasibility, possible new applications, and necessity of modification. Includes statistical analysis of bones within a patient database.

Developed and executed verification and validation testing for implants and instruments in an FDA regulated environment.

Wrote documentation for the submission of a 510k to the FDA for a novel implant design.

Wrote system requirements for the development of new surgical instruments based on customer needs.

Investigated and resolved noncompliance and nonconformance including the implementation of a UDI system.

Working knowledge of EN ISO 13485: 2012, EN ISO 14971: 2012, and 93/42/EEC Medical Device Directives (MDD).

UNIVERSITY OF MIAMI, CORAL GABLES, FL

Student Athlete Mentor, Jun 2011 – May 2013

Teach students study skills, note-taking skills, and test-taking strategies.

Provide private instruction to individual or small groups of students to improve academic performance, improve occupational skills, or prepare for academic or occupational tests.

Collaborate with students, parents, teachers, school administrators, or counselors to determine student needs, develop tutoring plans, or assess student progress.

Provide feedback to students using positive reinforcement techniques to encourage, motivate, or build confidence in students.

Review class material with students by discussing text, working solutions to problems, or reviewing worksheets or other assignments.

EDUCATION

UNIVERSITY OF MIAMI, CORAL GABLES, FL

Biomedical Engineering Master of Science, May2015

Biomedical Engineering Bachelor of Science, May2014 COLLEGE ACADEMY AT BROWARD COLLEGE, Davie FL

High School Diploma, Jun 2010

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