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Mechanical Engineer Medical Device

Location:
South San Francisco, California, United States
Salary:
80000
Posted:
November 18, 2018

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Resume:

Bradley W. Los

*** ********* *****, ***** *** Francisco, CA 94080

650-***-**** ● ac7qfu@r.postjobfree.com

linkedin.com/in/bradley-los ● bradlos18.wixsite.com/website

SUMMARY: Professional and self-driven engineer seeking to provide mechanical and medical device expertise in a transcending, full-time Mechanical Engineer position. Previous experience includes mechanical design, statistical analysis, regulatory and quality assurance, and maintenance for medical devices and mechanical systems.

EXPERIENCE

C. Light Technologies – Berkeley, CA August 2018 – Present

Regulatory and Mechanical Engineer

Head engineer leading the mechanical design and product development, regulatory affairs, failure analysis, and human factors engineering for an opto-mechanical device aiding in the diagnosis and monitoring of neurological diseases.

Created 510(k) submission paperwork: Market Requirement Document, User Needs, and Design History File.

Designed and created a moving Model Eye for the company’s Tracking Scanning Laser Ophthalmoscope medical device.

Training and mentoring UC Berkeley Master’s Students to help aid in the product development involving human factors studies, Gage R&R studies, and regulatory affairs.

ProUnlimited Inc. at Genentech Inc. – South San Francisco, CA October 2016 – August 2017

Reimbursement Case Manager

Educated, informed, and assisted patients and health care providers on pharmaceutical reimbursement processes.

Achieved top performance reviews: Benefit Investigations, payer reimbursements, regulatory and administrative procedures.

Received advanced customer and managerial satisfaction through advanced technical and interpersonal communication.

ACADEMIC PROJECTS

Master’s Engineering Capstone Project “Workoutimal:” University of California, Berkeley September 2017 – May 2018

Produced a novel exercise bike with a passive control system that maximized energy output by optimizing pedaling velocity

Completed the life-cycle analysis via the motor driver hardware, Matlab simulation software, and primary market research

Increased the MATLAB simulation accuracy by 25% by incorporating a human free will function for each individual user

Smart Sleeve, Wearable Medical Device Project: San Jose State University May 2015 - May 2016

Designed and prototyped a novel, wearable medical device to treat, monitor, and prevent chronic elbow tendonitis and neuropathy via integration of an inertial measurement unit, oxygen sensor, and electrical stimulator into a compression sleeve

Performed Finite Element Analysis on the primary PTC Creo design to simulate stresses and strains applied when worn

Recorded a negative 0.34 correlation value between forearm acceleration and oxygen delivery via MATLAB

EDUCATION

University of California, Berkeley May 2018

Master of Engineering, Bioengineering, GPA 3.6/4.0

Relevant Courses: Orthopedic Biomechanics, Tissue Mechanics, Clinical Therapy Design, R&D Technology Management

San Jose State University May 2016

Bachelor of Science, Biomedical Engineering, cum laude (GPA 3.6/4.0)

Relevant Courses: Bioengineering laboratory, Biomechanics, Biotransport Phenomena, FDA Regulations

TECHNICAL SKILLS

Biomedical Engineering: Device Development Lifecycle, Clinical Trials, Prototyping, Process Validation and Verification

Software and Computer-Aided Design: AutoCAD, SolidWorks, PTC Creo, MATLAB, Python, C, LabVIEW, COMSOL

Statistical Analysis: DOE, Characterization and reliability testing, Feasibility Studies, Root Cause Analysis

Medical Device QMS and Regulatory: FDA 21 CFR 820, ISO 13485, FDA submissions, Quality Assurance, FMEA, DFMEA

Laboratory: Polymerase chain reaction, DNA Extraction, Chromatography, Spectrophotometry, Assays, Electrophoresis

ADDITIONAL INFORMATION

Relevant Certification: Radioactive Chemical Safety Course Certification

Professional Academic Societies: Biomedical Engineering Society, Engineering Honor Society (Tau Beta Pi)

Volunteer Activities: Elementary School Teacher’s Aide, 8th Annual BMES Conference, and Youth Baseball Coach/Umpire

Language: Spanish - intermediate, German – novice



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