Nicholas Ferrer Email and Phone Number
Nicholas Ferrer work email
- Valid
- Valid
Nicholas Ferrer personal email
Nicholas Ferrer phone numbers
Biomedical/Electrical Engineer with a MS in Regulatory Affairs for Drugs, Biologics and Medical Devices focused on the quality and compliance of Medical Devices. Demonstrated skillset features are ISO 12207, ISO 13485, ISO 14155, ISO 14971, ISO 15223, ISO 62304, ISO 9001, and 21 CFR compliant product development, auditing, regulatory submissions, and post-market activities.
Mass General Brigham
View- Website:
- massgeneralbrigham.org
- Employees:
- 11852
-
Mass General BrighamJohnston, Ri, Us
-
Senior Quality EngineerMass General Brigham Oct 2022 - PresentSomerville, Massachusetts, UsTransforming the clinical industry with cutting-edge artificial intelligence (AI) technology. This position supports the Data Science Office and Digital Clinical Research Office (CRO) ensuring compliance with international, regional, local, and cultural standards/regulations.
-
Sr. Quality Systems EngineerPerkinelmer, Inc. Jun 2017 - Nov 2022Shelton, Ct, Us•FDA Inspection front/back-room support •Internal Audits - site process manager -proficient in ‘ISO 19011 - Guidelines for auditing management systems•Management Review - site process manager•Create, Review and Release engineering change orders for medical devices, new products, and supporting documentation• Create and maintain Quality System Management procedures establishing compliance standards• Primary resource for medical device Software Release - change order reviewer/approver; responsible for transfer of software into production environment• DHR - quality review and approval of finished medical devices -
Quality Assurance EngineerZoll Medical Corporation Sep 2016 - May 2017Ma, 01824, UsEN 60601-1:2012 Compliance EN 60601-1-2:2015 Compliance EN 60601-2-4:2011 Compliance EN ISO 14971:2012 Compliance EN ISO 15223-1:2012 ComplianceANSI/AAMI EC12:2000 ComplianceANSI/AAMI EC53:2013 ComplianceAAMI DF80:2003 ComplianceDesign History File Auditing: • System Requirements Documents • Design Input / Output Guides • Usability Specifications • Risk and Hazard Analysis • Design Verifications and Validations • DFMEAs • PFMEAs • Material Specifications • Standard Inspection Procedures • Standard Operating Procedures -
Biomedical EngineerXimedica Jan 2016 - Aug 2016Providence, Ri, UsDesign of ExperimentsClass 7 & 8 Clean Rooms: • Installation Qualification Protocol generation • Operational Qualification Protocol generation • Performance Qualification Protocol generation -
Clinical Research AssociateIlluminoss Medical Inc. Jan 2015 - Dec 2015East Providence, Ri, Us• ICH/GCP Certification.• Maintained study trackers/ dashboards to assist management with ongoing oversight of clinical trial program.• Responsible for the distribution and management of clinical trial supplies.• Reviewed and tracked site visit reports. • Assist in administrative tasks/ Prepare submissions to Ethics Committees and Competent Authorities under supervision.• Review site budgets and assist in overall study payments.• Maintained Trial Master Files.• Participated in vendor meetings and internal study team meetings.• Assisted with overall study management for 3 orthopedic device clinical trials in US and Europe that will be used for regulatory submissions. -
R & D EngineerIlluminoss Medical Inc. Nov 2010 - Dec 2015East Providence, Ri, Us• Built prototypes, models, test fixtures and mechanical systems.• Provided product/material testing and evaluation of statistical analysis.• Independently designed and executed simulated-use experiments, which included data analysis and communication regarding improvements.• Wrote and revised technical documents including SOP’s, design verifications, test protocols and reports.• Optimized data management system by enhancing the maintenance of accurate and up to date records, including appropriate lab notebook recordings.• Experience operating in clean rooms and with FDA Systems Regulations.• Produced manufacturing documentation for medical devices that incorporates the input from cross-functional and highly dynamic development teams.• Managed several projects from conceptualization to production of various medical devicecomponents/accessories including the generation and maintenance of the Technical Files.• Development and creation of Instructions for Use, Surgical Technique Guides and Labeling forcommercial/ clinical product.
Nicholas Ferrer Skills
Nicholas Ferrer Education Details
-
Northeastern UniversityBiologics And Medical Devices -
University Of Rhode IslandElectrical Engineering
-
University Of Rhode IslandNanotechnology
Frequently Asked Questions about Nicholas Ferrer
What company does Nicholas Ferrer work for?
Nicholas Ferrer works for Mass General Brigham
What is Nicholas Ferrer's role at the current company?
Nicholas Ferrer's current role is Transforming the healthcare and medical device industries using Artificial Intelligence (AI).
What is Nicholas Ferrer's email address?
Nicholas Ferrer's email address is ni****@****mer.com
What is Nicholas Ferrer's direct phone number?
Nicholas Ferrer's direct phone number is +140133*****
What schools did Nicholas Ferrer attend?
Nicholas Ferrer attended Northeastern University, University Of Rhode Island, University Of Rhode Island.
What skills is Nicholas Ferrer known for?
Nicholas Ferrer has skills like Medical Devices, Engineering, Fda, Product Development, Biomedical Engineering, Validation, Microsoft Office, Cross Functional Team Leadership, Design Of Experiments, Design Control, Manufacturing, Leadership.
Who are Nicholas Ferrer's colleagues?
Nicholas Ferrer's colleagues are Karen Giannopoulos, Jephté Soulouque, Samantha Doyle, Ches, Michael Brown, Clarissa L. Palomba, Elyse Berlinberg, Kimberly Gaulin.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial