Lead executing Software Maintenance Plans for SiMD in compliance with IEC62304 and BD procedures.Provide Product Risk Analysis (PRA) support for commercially released SiMDImprove and create new processes and procedures related to custom manufacturing software used to automate manufacturing processes based on latest industry trends; including IOT, AI and data-driven technologies (Industry 4.0).Assure software used in manufacturing/testing equipment, computerized systems, and spreadsheets have been validated for its intended use according to BD processesDevelop, execute and provide critical review/approval of software validation documentsWork in close partnership with business units to assure software is validated and maintained in a state of compliance to support business operationsEnsure compliance with department and company proceduresTrain and provide guidance to teams on the software validation process

• Managed team of 3 engineers addressing validation of test methods and software validation for automated manufacturing and test methods.• Owner/co-author of pre-validation specifications for automated sewing of prosthetic aortic surgical valves (user requirements, functional requirements and software architecture and configuration documentation) and winner with automated In-Line Stitch (ILS) team for Edwards Lifesciences 2021 GSC & Quality Excellence Award for Innovation.• Led validation team for upgrading of vision system hardware on legacy testing device for forward flow and leaflet coaptation testing for all Edwards heart valves.• Core team member for development of next generation automated vision system (ALM) for Edwards heart valve leaflet coaptation. Owner and coauthor for system specification, system hazard analysis, and project validation process specification. • Led software validation team for next generation testing platform (VES) for forward flow and leaflet coaptation testing for all Edwards heart valves. Owner and coauthor of associated software specifications, requirement traceability matrix, project validation process specification, software design document, software validation protocols and reports.• Completed first validation of Zeiss CT Scanner coupled with Zeiss Calypso software for the purposes of first article inspection without requiring test method validation (only 1 of 5 CT Scanners possessed by Edwards Lifescience having been validated). Author of software validation protocol and report.• Member of core team redesigning Edward Software Validation process for non-product manufacturing and testing equipment with 2019 release. Coauthor on all associated procedures, templates and training documents. • Owner and closed two CAPAs resulting from internal audits on process validation internal audit findings. Authored and completed root cause investigation, action plans, and effectivity monitoring.

• Managed team of 5 quality engineers and 1 technician for Medtronic Neurovascular Access Franchise (guide catheters, micro catheters and guide wires).• Design quality engineering core team member for two commercialized line extensions, one new guide catheter design (ARC Intracranial Support Catheter, FDA 510(k) number K150107) intended to support delivery of stentriever utilized in neuro mechanical thrombectomy, and two coating change projects (Navien Intracranial Support Catheter, FDA 510(K) number K161152; Reverse 021/027 Micro Catheter, FDA 510(k) number K171268). NPD effort included introduction of ANSI/AAMI HE75 recommended statistics for in-vitro physician validation.• Led design quality team remediation effort for acquired guide catheter DHF (DVT and Dval) in support of a traditional 510(k) submittal following a coating change. Effort included pilot of a new test method validation process which is now being prepared for use in internal Medtronic Neurovascular new product development.• Core team member (leading design quality function) for four post commercialization vigilance investigations; one, yield issues associated with catheter PTFE liner, two, impact of anatomical tortuosity on quadraxial deployment systems, three, impact of tri and quadraxial deployment systems on coating particulate generation, and four, failure of shelf life testing for shelf life testing. Efforts included root cause investigation, DOE verification, and containment reports.

• Developed and introduced MAKO’s risk management process and supporting SOPs for system operation, design, and manufacturing process (FMECAs, Hazard Analysis and Fault Tree Analysis) grading safety/efficacy risks and business risks with scoring systems based upon criticality and in compliance with ISO 14971. Led project teams on initial DFMECA and PFMECA and created associated documents.• Led approval and implementation effort for MAKO’s first major revision to it’s design control program since corporate IPO to address 21.CFR.820 audit findings (FDA and internal).• Developed configuration management process in compliance with ISO 10007. Methodology allowed tracking of the configuration of sequential robot builds produced late in the development process, but utilized in verification and validation activities.• Developed and introduced test method validation process focused on controlling appraiser variability for critical attribute and performance evaluation. Evaluated all MAKO legacy test methods and new methods developed during introduction of total hip arthoplasty application. Wrote all required protocols and reports for new methods and directed required testing and training documentation.• QA representative for retrospective MDR review of customer complaints to establish a more consistent process to meet 21.CFR.803 reporting requirements (yielded 120 MDRs reported to FDA in May 2012).• Led cross functional effort to review new product development specifications to ensure compliance with existing drawing methods and introduce GD&T methods (per ANSI Y14.5 1994) where relevant to clarify design intent and standardize inspection methods across geographically separated subcontractors. • QA resource for determination of CAPA root cause on robotic malfunctions and remediation actions where necessary.

• Developed expediting strategy for development of new 4.0 mm stent delivery system in 6 working lengths for a cardiac drug eluting stent and ensured readiness of finished design to support IDE submittal. Prototype evaluation and resultant concept selection report focused on demonstrating required reliability within required confidence intervals for critical design outputs (balloon nominal compliance, rated burst pressure, multiples inflation cycles until burst, and working length).• Coordinated development and identification of physical test methods projected to be utilized for design verification and validation of technical design inputs for a cardiac drug eluting stent as expressed by the product description. Established compliance with all relevant regulatory requirements (including FDA January 2005 Guidance on intravascular stents and delivery systems), compendial methods, and internal Cordis requirements. Developed new test methods where necessary and validated where appropriate.• Developed a leaned out test flow intended to minimize material consumption and execution time for full performance date collection to support IDE submittal. This effort included documentation of methodology utilized to demonstrate statistical sufficiency for product performance by phase gate.• Functioned as project lead for all listed efforts, which included schedule development, identification of project schedule risks and assumptions, resource allocation, and responsibility for team performance and deliverables production within projected schedule timelines.

Led project team for Quality Department mapping out current medical device returns process for Distribution Center and developing new lean process utilizing value stream mapping. Developed new returns process with governing SOP’s, employee training standards, packaging visual acceptance criteria, and return performance parameter reports to guide distribution center in future process improvements and resource allocation.

• Designed micro filtration, ultra filtration, and chromatography systems for use by pharmaceutical and research universities. Responsible for all mechanical elements controlling fluid mechanical environment including specification and purchase. Executed all associated drawings, from mechanical arrangement through piping isometrics and manifold fabrication utilizing ProEngineer Wildfire.• Configured ProEngineer and ProIntralink for server distributed operation. Created start parts, Intralink database folder design, standard engineering release levels/processes, and standard part libraries. Designed filtration system configurations with standard options available to designer utilizing ProProgram.

• Certified as six-sigma black belt in March 2003. First 2 projects netted over $100,000 annually in cost avoidance and direct savings through implementation of robust designs determined through DOE’s.• Through equipment manufacturing product support requests, identified opportunities to improve the quality of existing products and utilized six-sigma tools to determine root cause and develop innovative robust solutions. Strong dependence upon process mapping, capability data and project charters in justifying engineering changes.• Specialized in design and specification of injection-molded parts, CNC machined parts, composites, lubricants, sheet metal framing, and mechanisms.

• Lead mechanical engineer for a new generation high speed rotating sterilizing filter; new product resulted in multiple patents; awarded top contributor award at Cortland R&D facility in 1994 for original design effort.• Directed subcontractor construction of laboratory prototypes for above technology and directed mechanical team developing rotating machinery and machine platform. Original efforts included a cartridge style bearing frame with vertically cantilevered rotor, one-piece e-beam welded filter rack, and a sanitary style composite gasket.• Codeveloped technical specifications for special Variable Frequency Drive (VFD) controlled electric motors, 316L SS, and mapped baseline behavior for machine prototypes with regard to temperature profiles, energy consumption, and vibration signature.• Established electronic database to archive all team ProE documentation at Pall. Developed guidelines for large assembly and family table management for new product family. Established part and assembly templates with user defined parameters for rapid extraction of pertinent engineering data from PDM program. Managed and established technical documentation and specification requirements.• Initiated six-sigma tolerance analysis for Pall machinery platform design and manufacturing through RAND Corporation’s CE-TOL.