Avi Alishaev
Quality Engineer II at Medtronic
Quality Engineer at Medtronic
•	Self-starter and engineer with a strong educational background in biomedical engineering, supported by research in tissue engineering/ biomaterials and 4+ years of professional work experience in Class II/III medical device testing, post-market risk management and quality assurance, and process development.
•	Eager to be a part of a team of engineers in a creative, fast-paced environment to collaborate novel ideas for improving product and process designs for medical devices.
Medtronic
https://www.linkedin.com/company/medtronic
Quality Engineer II
Jacksonville, Florida, United States
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Medtronic
https://www.linkedin.com/company/medtronic
Quality Engineer
• Updated the risk management file for a newly acquired company’s class II medical device.
• Executed process validations (e.g. MSA, OQ) to aid in product manufacturing transfer. 
• Performed investigations on trending product complaints to assess risk and recommend corrective actions, if necessary.
Jacksonville, Florida, United States
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Edwards Lifesciences
https://www.linkedin.com/company/edwards-lifesciences
Quality Engineer
MDD/ EU MDR Quality Engineer

- Update legacy risk and quality documentation (RMP/ RMR, FMEA, BRA, QCP) for MDD certificate renewal for class I and II medical devices.
- Identify and bridge gaps in risk and quality documentation between MDD standards and new EU MDR standards for class III medical devices, including heart valves and rings.
Irvine, California
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Cook Medical
https://www.linkedin.com/company/cookmedical
Product Remediation Engineer
• Investigated product nonconformance, including development of a risk management plan, clinical effects analysis, hazard analysis, FMEA, and risk management report. 
• Identified user needs and developed into design input requirements while following design control procedures.
Bloomington, Indiana
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Medtronic
https://www.linkedin.com/company/medtronic
Quality Assurance/ Regulatory Affairs Engineer
• Performed quality assessment reviews of device malfunctions and clinical adverse events, assigned harms and severities for repeatability determination, and identified/ escalated trends in order to ensure complaint management system compliance to requirements issued by FDA and international regulatory bodies.
Miami Lakes, FL
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Medtronic
https://www.linkedin.com/company/medtronic
Test Engineer
• Devised and administered exhaustive characterization testing for proposed design changes to ventricular assist devices, with the ambition to reduce the occurrence of unfavorable clinical events.
• Streamlined production processes on the manufacturing floor by discovering and redesigning outdated and inefficient tools and procedures, while diagnosing and refining out-of-control processes with the use of statistical process control.
Miami Lakes, FL
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HeartWare Inc
https://www.linkedin.com/company/heartware-inc
Engineering Intern
• Constructed simulation setups of the circulatory system using mechanical equipment for LVAD design change research and development.
• Analyzed and interpreted data, generated engineering test reports, and assembled project presentations to update the Chief Scientific Officer and Senior R&D Engineers.
Miami/Fort Lauderdale Area
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Bar-Ilan University
https://www.linkedin.com/company/bar-ilan-university
Chemistry Laboratory Intern
• Synthesized antibacterial metal-containing polydopamine nanoparticles and examined their antibacterial activity using ultrasound sonochemistry.
• Immobilized lysostaphin onto polydopamine-modified surfaces and analyzed their antibacterial and antibiofilm response using spectrophotometry.
Ramat Gan Area, Israel
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Biomedical Engineering
Master of Science - MS
University of Miami
https://www.linkedin.com/school/universityofmiami/
• Design Project: Customized a handmade 3D printing system to print biomaterial scaffold structures for use in cell culture and analyzed the effect of varying scaffold architecture on cell morphology of 3T3 fibroblasts.
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Biomedical Engineering
Bachelor of Science - BS
University of Miami
https://www.linkedin.com/school/universityofmiami/
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Alpha Eta Mu Beta Biomedical Engineering Honor Society
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Tau Beta Pi Engineering Honor Society
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Biomedical Engineering Honor Society
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Sonochemically produced metal-containing polydopamine nanoparticles and their antibacterial and antibiofilm activity
Langmuir
•	Synthesized antibacterial metal-containing polydopamine nanoparticles using ultrasound sonochemistry and examined their antibacterial activity.
Advanced Biomaterials
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Biomedical Systems Engineering
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Cell and Tissue Engineering
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Engineering Management
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Introduction to Programming
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Probability and Statistics
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Regulatory Control of Biomedical Devices
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Scanning Electron Microscopy
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Science and Technology
U.S. Department of Veterans Affairs
https://www.linkedin.com/company/department-of-veterans-affairs
Student Laboratory Assistant
• Characterized human stem cells of a newly identified mesenchymal stem cell line (MIAMI cells) from various demographics utilizing cell culture, cell counting, and flow cytometry skills, while showcasing teamwork in a laboratory research setting in the University of Miami medical campus.
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https://www.linkedin.com/in/iammalhar
Malhar Shah
Quality Engineer I at Medtronic
Boulder, CO
https://www.linkedin.com/in/saumya-patel-09551230
Saumya Patel
Technical Support III at Medtronic
Broomfield, CO
https://www.linkedin.com/in/jessica-desai
JESSICA DESAI
Senior Regulatory Affairs Specialist at Medtronic
Denver Metropolitan Area
https://www.linkedin.com/in/iravati-ambike
Iravati Ambike
Quality Engineer | Health-tech | MS Biomedical Engineering
Mountain View, CA
https://www.linkedin.com/in/rose-merlin-jose
Rose Merlin Jose
Regulatory Affairs Specialist | Quality Engineer | Looking for new opportunities in the Medical Device Industry
Dallas-Fort Worth Metroplex
https://www.linkedin.com/in/rayid-sakib
Rayid Sakib
Senior Quality Engineer at iota Biosciences | Start-Up
San Francisco Bay Area
https://www.linkedin.com/in/zaintbhatti
Zain Bhatti, M.S
Sr. Engineering Consultant at Stryker| Multiple years of Medical Device Experience| EU MDR, 510k, Remediation, R n D | Masters in Biomedical Engineering| US Citizen
Raleigh, NC
https://www.linkedin.com/in/sachinjose91
Sachin Jose
R&D Engineer at Medtronic
Irvine, CA
https://www.linkedin.com/in/reneepauline
Renée Pauline Perez
Associate at Jones Day
San Francisco, CA
https://www.linkedin.com/in/eduardo-rangel
Eduardo Rangel
Building and Improving Technology for Better Lives
Miami, FL
https://www.linkedin.com/in/edward-burkot-63161ab6
Edward Burkot
Quality Engineer at Emergent BioSolutions
Baltimore, MD
https://www.linkedin.com/in/alyssarosenfeld
Alyssa Rosenfeld
Senior Quality Engineer at Medtronic
Miami, FL
https://www.linkedin.com/in/miranda-vargas
Miranda Vargas
Manufacturing Engineer at Cook Medical
Ellettsville, IN
https://www.linkedin.com/in/wujoi
Joi Wu
Mechanical Engineer & Talent Ambassador | Space Systems | Northrop Grumman - Now hiring DoD cleared engineers.
Salt Lake City Metropolitan Area
https://www.linkedin.com/in/michael-mei-58b5956a
Michael Mei
Quality Engineer at Stryker
Miami, FL
https://www.linkedin.com/in/kristen-shimabukuro-999b8ab3
Kristen Shimabukuro
Physical Therapist at JACO Physical Rehab
Honolulu County, HI
https://www.linkedin.com/in/alexandercaballero
Alexander Caballero
Honeywell Aerospace | Systems Engineer II
Phoenix, AZ
https://www.linkedin.com/in/amyagramonte
Amy Agramonte
Director of Professional MBA  at University of Miami
Miami, FL
https://www.linkedin.com/in/rachel-chapnick-748762123
Rachel Chapnick
Requirements and Capabilities | Air Power | Raytheon Technologies
Shalimar, FL
Approximately 40% of contact lens wearers suffer from itchy eyes due to ocular allergies.* Johnson & Johnson Vision is pleased to share that the US…
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Looking for a referral for a reliable architect for two home-addition projects, both located in Miami FL.
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Thanks to advances in battery technology, Medtronic neurostimulators and neuromodulation systems have faster recharge times — giving patients more…
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3D Printing Today
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Medical Device Opportunity
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Cell Therapy Industry group
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Entry Level Engineers
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MedTech Innovation (Photonics, 3D Printing, Robotics, Ultrasound), powered by Jakajima
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Alpha Sigma Phi Fraternity - Medical Professionals
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Society for Biomaterials
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The Science Advisory Board
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🔥 MedicalDevicesGroup.net 🔥
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University of Miami Alumni Association
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Entry Level Biomedical Engineers
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Future Science Group
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Medical Device Engineering Professionals
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Biomedical Engineering Division (BmED)
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