Robert Faust Email & Phone Number

Raymond, NH, US

• Preparation and Complete US FDA 510(k) submissions
• Preparation of MDR Technical File submissions to the Notified Body
• PRRC – Person Responsible for Regulatory Compliance (EU MDR)
• Preparation and Completion of Non-significant Change requests to the Notified Body
• Maintenance of MDD Technical Files
• Support US and non-US product registrations, approvals, and licensing

• Understand and applies current global product safety regulations pertaining to medical and information technology equipment. Reviews emerging regulations for potential impacts and proposes compliance plans
• Provides engineering support to new product commercialization teams to ensure compliance of products before market release
• Consults with existing manufacturing teams to ensure compliance of process modifications or new construction
• Maintains testing & product configuration data to demonstrate continued compliance
• Reviews & approves safety related information prepared for manufacturing, end-users and service personnel (e.g., final product testing, User Guides, marketing brochures, web site, procedures, etc.)
• Assists in the compliance planning & use of external testing services

Andover, MA

 Provide standards compliance consultation to Philips business lines during product development including standards based risk management requirements, usability requirements, software requirements, essential performance requirements and clinical accuracy requirements. Support project testing by advising, planning, and reviewing and signing test results.

Merrimack, NH

 Lead design assurance QA / Regulatory Engineer on 3 development programs, ensuring that programs complete all required actions within the product life cycle. Including tracking build configuration (on Verification Units / Beta systems) that will support verification for FDA submission.  Provided regulatory support for legacy programs, ensuring that they.

Manchester, NH

Build relationships with and coordinate certification testing at multiple NRTL / CB testing facilities. Prepare projects for evaluation and submission to IEC/AAMI/EN 60601-1:2005+A1:2012, IEC 60601-1-11, IEC 60601-2-24 and IEC 60601-2-39. Reviews EN ISO 14971:2012 Compliance.Reviews IEC 62304 Compliance.Completes design review of products and modules to.

CB Certified Project Report Reviewer. Provide training and guidance to fellow compliance engineers. CB Certified Medical Engineer to AAMI, IEC, CENELEC, EN, UL, CAN/CSA 60601-1 2nd and 3rd editions. Evaluated products to the following standards: 60601-1-1, 60601-1-4, 60601-1-6, 60601-1-8, 60601-2-4, 60601-2-25, 60601-2-27, 60601-2-30, 60601-2-34.

Perform critical product safety testing and compliance evaluation to IEC / UL 60950, 60335, 61010 standards.

Perform critical product safety testing to IEC / UL / EN / ANSI / AAMI 60601-1, 60601-1-1, 60601-2-4, 60601-2-25, 60601-2-27, 60601-2-30, 60601-2-49, 60601-2-51, 9919, 746, Risk Management 14971 standards. Test for mechanical, electrical, and environmental effectiveness, identifying exposed mechanisms that might cause injury to a user. Applied engineering.

Factory Inspector / Auditor, verify at the customer’s location that TUV NRTL GS critical safety components are being manufactured / produced with all required safety components. Manage test lab to ISO 17025 / A2LA and OSHA CB accreditations. Perform critical product safety testing to IEC / UL 60950, 60335, 61010 standards. Capture critical test data and.

Calibrate, maintain and repair of complex high vacuum leak detection equipment (Veeco, VIC and Pfeiffer), Ericsson single fusion and mass fusion fiber optic splicing equipment, room temperature/humidity recorders, high voltage test sets, and x-ray equipment. Troubleshooting of installed equipment on site. Monitor and coordinate progress for assigned.

Train authorized distributors at the customer's location. Provide technical phone support to our authorized distributors. Work with electrical, mechanical and pneumatic assemblies. Troubleshooting of installed equipment on site. Perform quality audits (AQL) at our warehouse locations. Create detailed reports for quality group. Assist engineers to improve.

Led installation and troubleshooting of new and modified electronic equipment used to collect television-viewing data. Provided customer service work in households. Graduated first in my class from Nielsen Training School. Manage / schedule my assigned work by analyzing priorities and customer needs.

Diagnosed and problem solved to component level product failures; used oscilloscopes, multimeters, and other engineering principles. Worked to troubleshoot and debug installed equipment and the according testing procedures. DWDM, DDM, TDM, and Sonet Fiber Optics Shops: OC3, OC12, OC48, OC192, Lambda Router, with environmental and functional and systems.

Experience at Lechmere, Cambridge Sound Works, and Eastern Mountain Sports. Recognized for strong Customer Service skills. Achieved sales record as