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• Develop regulatory strategies to enable efficient and timely market clearance / approval with consideration of future business direction• Provide regulatory oversight and guidance to new product development teams• Support product engineering/manufacturing staff to review, assess and approve product modifications to determine appropriate regulatory requirements• Review and approve customer publications, labels, marketing, advertising and/or promotional materials for compliant and accurate content• Assist and review CAPA document plans and provide guidance for root cause analysis and efficacy checks• Provide expertise on applicable medical device regulations to business partners• Supervise 3 employees

• 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• Reviews and prepares, as necessary, compliance reports to regulatory agencies and management• Identifies & coordinates training to meet the needs of the engineering community• Interfaces and participates in site inspections from certification agencies• Participates, as needed, in the analysis & resolution of potential field related safety issues

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 and conducting tests. Conduct product reviews (IFU, Marking, Risk Management, Essential Performance, Software Life-Cycle Development and Usability) and inspections (Creepage Distance, Air Clearance, Alarms) according to standards requirements. Prepare formal product safety compliance verification reports for submittal to Third-party agencies and DHF verification vault. Participate in the product safety groups’ ISO 17025 quality management system including annual proficiency testing, training, corrective actions, preventive actions, audit action plan reports. Review upcoming standards while they are in draft status and provide comments back to technical committees. Participate in product safety group training events by leading discussions on IEC 60601-1-11, IEC 60601-1-12, IEC 60601-2-26, IEC 60601-2-30, IEC 60601-2-49 and IEC 60601-2-50.

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 maintain their approvals enduring part obsolesce and cost reduction efforts. Including any necessary gap testing.  Participant in the development and approval of product specifications and system requirements ensuring that the requirements will meet the required domestic and international regulations (IVD Directive, EMC Directive, RoHS Directive, IEC / EN / ISO and UL standards).  Reviewer and participant of EN ISO 14971:2012 Risk Management activities, including plan creation, risk scoring, risk mitigation, risk reduction and risk verification. Provided multiple EN ISO 14971:2012 Risk Management training classes. The audience was Systems and Quality Engineering. Training included implementing and understanding the EN ‘Z’ Annexes and the implementation of ISO/TR 24971:2013. Provided training on EMC – IEC 61326-1:2012 / IEC 61326-2-6:2012 standards, specifically improving radiated emissions (EN 55011 / CISPR 11) performance and ESD IEC 61000-4-2 compliance.  Managed the standards library, ensuring that the library was up to date with the latest standard revisions and remaining current on all domestic and international regulatory requirements.  Lead Regulatory / QA role on technical design review teams, including mechanical, electrical, systems requirements, software requirements and risk management reviews, ensuring that the reviews are completed per standard operating procedure, are documented correctly, meet all regulatory requirements and are correctly placed in the DHF – design history file.  Participates in ISO 13485 design control audits.

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 ensure compliance will be met.Create Test Plan, Oversee and Review: EMC testing to IEC 60601-1-2:2007, IEC 61000-3-2:2005, IEC 61000-3-3:2013, IEC 61000-3-4:1998, IEC 61000-4-1:2006, IEC 61000-4-2:2008, IEC 61000-4-3:2006, IEC 61000-4-4:2012, IEC 61000-4-5:2005, IEC 61000-4-6:2013, IEC 61000-4-7:2002, IEC 61000-4-8:2009, IEC 61000-4-11:2004.Technical Writer - Author test plans based off of product requirements and specifications.Oversee and manage execution of test cases / test plans.

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, 60601-2-37, 60601-2-49, 60601-2-51, 60601-2-58, 62366, 62304, 9919. Performs Compliance Reviews to Risk Management ISO 14971. Qualified Satellite 1, 2 and 3 Assessor to ISO 17025. Offer leadership by providing training for other engineers and technicians. Utilize outstanding communication skills to strengthen relationships with customers. Consistently exceeds expectations by consistently completing projects ahead of schedule. Willingness to accept new responsibilities and thrives with the opportunity to go above and beyond expectations. Provide expert technical guidance to alleviate customers concerns and problems.Received Gold Star Award for superior customer service.

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 principles to evaluate properties, operations and limitations of devices under test daily, including use of: multimeters, function generators, oscilloscopes, and schematics / engineering drawings – to the component level. Improved and updated testing procedures. Write detailed technical reports derived from electronic and mechanical evaluation. Worked with OrCAD to create insulation drawings / diagrams.

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 incorporate it into robust technical reports. Work with and communicate directly to customers regarding issues. Applied engineering principles to evaluate, properties, operations and limitations of devices under test daily, including use of: multimeters, function generators, oscilloscopes, and schematics.

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 corrective action reports. Achieved and maintained Secret security clearance.

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 product quality and performance.

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 tests. Trained fellow associates in testing processes, analyzing techniques, and cellular manufacturing.

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