Quality Engineer, Quality Assurance, Validation Engineer
Resume:
Nolan Ryan, BS Biomedical Engineering *********@*****.***
I am a medical device professional with experience in Validations, Quality Assurance, and Regulatory Affairs. I have a strong understanding of the quality system developed through hands on experience from a myriad of projects. I am a highly motivated, ambitious self-starter with the proven ability to take on all types of projects, successfully complete them with a high quality of work, and work cooperatively with cross functional teams.
CURRENT Regulatory, Quality, and Clinical Rotational Associate July 2014-Present
Integra LifeSciences
Quality Validation Engineer – Plainsboro, New Jersey - Collagen Manufacturing Center – Orthopaedics and Tissue technology Division (November 2015-Present)
oGenerate and execute equipment installation, operation, and performance qualification protocols
oGenerate and execute process validation protocols
oPrepare final reports for executed protocols
oSupport Audit Team for FDA Pre Approval Inspection for a manufacturing facility
Quality Assurance – San Diego Manufacturing Facility – Specialty Surgical Solutions Division (March 2015-November 2015)
oOrganized and led team in the creation of product DMRs and updates to related procedures
oManaged the Audit Readiness team for FDA and BSI Audits.
oOrganized Audit Remediation activities for outstanding Non-Conformances
oCreated Sterilization Validation Protocol for a packaging redesign project.
oLed team in creation and presentation of quarterly Quality Management Reviews.
oAdditional responsibilities included work with CAPAs, NCs, Complaints and Risk Analysis.
Regulatory Affairs – Plainsboro, New Jersey - Orthopedics and Tissue Technology Division (July 2014-March 2015)
oWorked with cross functional team to draft and submit a PMA Panel Track Supplement for expanded indication for use. The PMA has been received FDA Approval.
oWorked with cross functional team to draft an original CE Renewal and multiple deficiency responses for CE Renewal for multiple products.
oPerformed the update for multiple products Design Dossiers
oSupported International and Private Label Regulatory Teams for product registration
oDrafted Change Notification for submission to EU Notified Body
oDrafted 510(k) submission
EDUCATION Rensselaer Polytechnic Institute (RPI), Troy, NY May 2014
Bachelor of Science in Biomedical Engineering, Biomechanics Concentration GPA 3.55/4.0
Minor in Psychology
RELATED Nelson Laboratories Seminar – Science of Sterilization Sept. 22-Sept. 24 2015
AAMI Course - Quality System Requirements and Industry Practice Sept. 29-Oct. 3 2014
AdvaMed Workshop - 510(k) Submission Oct. 20-21, 2014
Research Assistant, Dr. Hamish Kerr, Capital Region Orthopaedics Dec. 2013-May 2013
Responsible for data acquisition and analysis of accelerometer data with a custom built LabVIEW VI to better understand the biomechanics behind concussions in MMA fighting.
Department of Orthopaedics, Mass General Hospital
Research Assistant/Summer Intern, Sports Performance Center Summer 2013
Transformed the data management system of the center. Assisted on biomechanical research and clinical evaluations using 3D motion analysis. Collected data with the Vicon Nexus camera system and analyzed the data using Visual 3D and Matlab. Worked directly with the clients in a clinical setting.
Research Assistant, Bioengineering Laboratory Summer 2012
Built 3D computer models of knee joints and analyzed cartilage contact during step up activity.
Research Assistant, Biomedical Engineering Lab RPI Dec. 2011- June 2012
Designed a tension device to fit in a spectrophotometer that would allow the user to apply a known force.
ADDITIONAL Technician, Cape Cod Oyster Co., Osterville, Massachusetts June 2007- June 2014
EXPERIENCE
PROJECTS Senior Design
Designed a diagnostic tool that isolates and measures the strength and functionality of specific muscles of the neck. The goal of the project was to create a device that allows for objective diagnostics of damage to the neck musculature after a concussion.
Biomechanics I&II
Built a prototype bandage that could apply multidirectional, alternating forces to a wound to aid in the healing process.
Bioengineering Lab
Designed an experiment to test the strength of a chicken tibia that would be fitted with an external fracture plate. Performed various other experiments using lab techniques such as ultrasound, voice recognition, EMG, MTS, and spectrophotometry.
PUBLICATIONS Li J-S, Hosseini A, Cancre L, Ryan N, Rubash HE, Li G. Kinematic characteristics of the tibiofemoral joint during a step-up activity. Gait and Posture 2013;
http://dx.doi.org/10.1016/j.gaitpost.2013.03.004
SKILLS Computer: LabVIEW, Vicon Nexus, C-Motion Visual 3D, Microsoft Office
Experience with: Matlab, Nx 7.5, Solidworks, Rhino
Engineering: Metal and wood work with lathe, vertical and horizontal miller, drill press, welding and brazing, plastic welding
LEADERSHIP Eagle Scout Dean’s list
& HONORS Graduated Cum Laude Rensselaer Leadership Award
Integra Orthopedics and Tissue Technology Spotlight Award – Q1 2015
Club Ultimate Frisbee Vice President and Captain
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