• Oct 2021 – present – Business Unit Lead for Medical Devices – responsible for BU profit & loss, strategy and direction of business unit (including recruitment, monitoring progress, sales, marketing, training & development, services to be developed), 25 FTE & 11 subcontractors, largest BU – responsible for >50% of total company revenue • Jan 2020 – Oct 2021 – Service & Development Manager – technical lead for service development• Nov 2015 – Dec 2019 - US Team Manager – Sales & marketing, operations, technical consulting, team management. Assist medical device manufacturers with the CE marking process in order to gain access to the European market, as well as addressing their general strategic and tactical RA/QA/CA questions with regard to pre- and post-market requirements for the European, US, Canadian, Japanese and Chinese markets. Team Manager – 7 direct reports and 5 subcontractors.

Teaching and course development in the RegSci program at USC, including - Overview of MDR, Standards and More Standards and Working with a Notified Body lectures in course MPTX 511 (2010-)- Course Instructor for RSCI 507 Quality Systems and Statistical Process Control (2016-)- Course Instructor for RSCI 520 Introduction to Risk Management for Healthcare Products (2022-)

Instructor for the 2 unit (32 classroom-hour) course "Quality Systems and Statistical Process Control" (RSCI 507), which is part of the MS in Medical Product Quality.

Guest lecture in the MPTX Global Regulation of Medical Products course (which is part of the MS in Regulatory Science program).Lectures:- Working with a Notified Body- Standards .... and more Standards!

Responsibilities include:• Hosting, organizing front and backroom logistics, and strategizing for all external audits/inspections (FDA, Notified Bodies, other regulatory agencies), including the following results: o ISO 13485 recertification audit (3 sites, 16 auditor-days) with zero (0) non-conformities o FDA QSIT inspection (1 site, 8 investigator-days) with zero (0) 483s. • Quality System Governance (i.e. ensuring the QMS is compliant to all relevant regulations, including interactions between the various processes)• Internal Audit Program (design, execution and management)• Management Review (designing the process and providing input to the Management Rep. for execution of the required meeting)• Developing and building a new Regulatory Compliance team to execute the teams responsibilities (6 direct reports, 14 in team)• Department budgetingSkills gained:• Team management, functional management• Deeper understanding of 21CFR820, 803, 806, ARO and electronic product requirements• Practical understanding of designing and controlling a QMS to simultaneously meet US, European, Canadian and Japanese regulatory/Quality System requirements• Practical understanding of designing and controlling a QMS which covers an active medical device, including ‘capital equipment’, ‘installation & servicing’, and ‘software development’ aspects (including anomaly handling)• Better understanding of the challenges of operating a QMS in a multi-site, international, mid-size (1000+ employees) organization• Deeper understanding of 60601 series requirements, as well appreciation for EN 62304 requirements• Understanding of radiation oncology clinical aspects and workflows

Cardiovascular Product Expert (Head of Group)Drug-Device combination product Product ExpertPerform product assessment, consisting of review of design dossiers and on-site auditing, in order to verify compliance to 93/42/EEC MDD (including medicinal substance-device combination products and consultation with drug authorities)Conducted over 200 design dossier/technical file/change reviews and over 100 audits of all types Clients are multi-site international companies, and start-ups, with high technology, innovative productsConsistently top performing revenue earner at DEKRA Certification.Skills gained- Thorough understanding of CE Marking process, MDD requirements, ISO 13485:2003, CMDR-part 1 and CMDCAS, ISO 17021, ISO 19011- Understanding of US FD&C Act and 21 CFR parts 11, 801, 803, 806, 807, 820 and 821. - Familiarity with JPAL requirements.- Expert Design Dossier Reviewer (including BMS, DES, Bioresorbable stents, LV partitioning devices, Heart valves, Mitral valve coaptation devices, Annuloplasty rings, Sidebranch stents, PTCA catheters, Neurovascular foreign body retrievers, Thermal catheters, CVCs and Implantable ports, Dermal fillers, Knee implants, Voice prostheses and IOLs) - Expert CE auditor (conducted audits in USA, Mexico, Canada, Ireland, Costa Rica and Japan)- ISO 13485:2003 Lead Auditor- CMDCAS qualified auditor (certificate # M-1879)- ASQ Certified Biomedical Auditor (certificate # 1047; expiration June 2016)- Expertise in the following areas: ▪ Combination Products and eCTD requirements ▪ Clinical data and evaluation (ISO 14155; Annex X; MEDDEV 2.7.1, MEDDEV 2.12.2) ▪ Risk Management (EN ISO 14971:2012) ▪ Performance testing (Harmonized & product standards) ▪ Design Control ▪ Environmental Control & Monitoring (EN 14644; USP) ▪ Product and Process Validations ▪ Sterile Packaging (ISO 11607) ▪ Sterilization (ISO 11135, ISO 11137, Aseptic Processing EN 13824 and ISO 13408) and ▪ Biocompatibility testing (ISO 10993).

Managed R&D activities throughout the Oculus organization (USA, Mexico & The Netherlands)Developed R&D strategy to meet all business, regulatory, quality and marketing requirementsDeveloped Design Control proceduresManaged R&D engineers, technicians, consultants and contractors.Oversaw Intellectual Property portfolio and patent generationGenerated and managed the R&D budget (~$1M)Supervised & developed micro-biological, chemical, mechanical, electrochemical, electrical, biocompatibility and all other testing required by needs or goals of all Oculus functional areasSkills gained:• Higher Level Project Management• Patent preparation and IP portfolio management• Generation and Effective Implementation of immature Quality Management System.

Functional responsibilities included development of all next generation phased array scanners & delivery systems; providing technical support for OEM customers; recruiting and developing personnel and expanding group; budgetary responsibility (project and functional)Led team for process development to achieve improved manufacturing yields on “Eagle Eye”, with reduced costs and improved performance. Net yield increased from 70% to 80%.Directed the work of 8 technicians and 2 engineers during process development and of ~40 operators during V&V buildsDesign and fabrication of all new tooling and components for these processes/productProject Leader for “Eagle Eye” F/X Catheter – new phased array IVUS device (flagship project – first new IVUS catheter for 3 years; Achieved project deadlines in difficult circumstances [i.e. sale of company])Skills gained:- Functional Management in a Matrix Management Structure; Project Management & Leadership- Excellent communication skills with all levels, from CEO to operators. - Design Control requirements- Development of key vendor relationships - Many technical (flexible printed circuits; flip-chip; PZT arrays; bonding technologies; laser cutting) and statistical skills

Worked with emissive and Langmuir probes to diagnose an arc plasma. Daily working language was French.

I studied the edge plasma ("scrape-off layer", SOL) in a tight-aspect ratio thermonuclear plasma tokamak. My experimental work included the diagnosis of energy and particle fluxes to the divertor surface in the Small Tight Aspect Ratio Tokamak (START), using Langmuir probes and thermography.I built the Langmuir probe system, which interfaced with data acquisition hardware. I gained some basic knowledge of electrical circuit design and construction. Capacitors were also included in the circuits, to provide a local floating potential for the probes, due to the electrical plasma environment. Issues such as capacitive and inductive coupling and noise had to be addressed by suitable screening of the electrical circuits. I also wrote and maintained software for data acquisition and for analyzing the results of the electrical signals obtained by the Langmuir probes.The experiment was conducted under high vacuum, so knowledge of vacuum technology was also gained, including gasket technology and pumping. In addition, I learned about chemical and physical surface treatment with plasma, including chemical & physical sputtering, neutron exchange, absorption, desorption, evaporation and arcing