Commercializing the next generation of Life Sciences Instrumentation in the state of Virginia

Total Product Lifecycle Management for Life Sciences Instrumentation and FDA Class II & III Medical Devices.• Systems Engineering – Requirements Generation & Management, Product Design Specification, Testing for Verification & Validation.• Design Review, (including DFM), and Transfer from Design to Manufacturing (Production Engineering – manufacturing & test procedures generation, product release and packaging).• QMS generation and auditing/inspection for QA and Regulatory compliance against ISO 13485, 9001, and FDA cGMP QSIT. Risk Management for ISO 14971 also available.• Facility setup for manufacturing and overall Lean Process Flow - Class III, II, & I Medical Devices, IVD, MET Mark/CE, electromechanical instrumentation consultancy. • Aftermarket & Logistics Management. Distribution also available.• Product Launch into Domestic & International Markets.

• Initiated, established and managed ITL Group’s US-based Life Sciences facility from scratch. Grew the business year-over-year, leading to site expansion relocations, revalidations and new KPIs.• Setup and transferred contract service operations from Europe to the USA, including QMS procedures and infrastructure to allow manufacturing, product servicing/repair, distribution & logistics, and customer support. • Obtained ISO 13485 & 9001 certification, lead BSI audits and FDA QSIT facility inspections.• Ultimately responsible for site QA & RA, final product release, IQ/OQ/PQ and pFMEA.• Act as Program/Project management through all stages of the product life cycle, from initial design requirements capture, costing & timelines, hardware procurement, production, packaging, and logistics.• Provide the platform and support for customers to launch products and services into the U.S. market for a variety of new and existing technologies, including a Nitric Oxide delivery system used for inhale therapy (Class II Medical Device), a Sentinel Lymph Node Detection System utilized for Breast Cancer (Class II Medical Device), an Extendable Pediatrics Prosthesis Limb Grower (Class II Medical Device), a Liver Transportation Perfusion System (Class III Medical Device), a Handheld Luminometer for ATP Sanitation Testing.• Performed new business development and marketing activities for the ITL’s core contract services in addition to its own product line (MET Certified electromechanical laboratory equipment and PCR testing consumable), acquiring a dozen North American based distributors within the first few years from inception.• Worked with ITL’s parent company (G&H) to obtain/onboard new Life Sciences projects with photonics systems integration, to allow synergies between the group’s different expertise and sites.

• A multidisciplinary role leading the project team, developing and managing design input system requirements in accordance with ISO 15288, for new medical devices and analytical instrumentation projects.• Generated and managed product specifications, trace matrix and testing documentation during development, performing theoretical and physical modelling in the areas of optics, electronics, mechanics and software for whole systems and sub-systems. Took part in Design Reviews.• Undertook risk identification (Hazard Analysis) and mitigation (Risk Management) activities to ISO 14971.• Assisted with generating and managing product technical files submitted for safety testing and regulatory approvals (CE & MET marking, IEC/UL 61010, ISO 60601, FDA 510(k) & PMA submissions).• Undertook verification & validation (usability/human factors) activities to ensure design output met input.• Transferred products from design and development into production via Design Transfer protocol for DMR generation, with input into CA/Commissioning testing and DHR contents.• Successfully took a number of complex products through various stages of the product development life cycle, including: a Digital Colposcope used to map Cervical Cancer (Class II Medical Device), a platform Point-of-Care Lab-on-Chip/Real Time PCR system used to detect Infectious Disease (Class II IVD), a Spectroscopic Chemometric System used for the detection of Mycotoxins in foods (MET certified lab equipment).

• Prepared various systems test and experimentation documents along with conducting the associated tests. Undertook In Vitro and In Vivo (porcine model) feasibility studies and built proof of principal instruments, prototypes and finished pilot production products.• Successfully took a number of complex products through various stages of the product development life cycle, including: a Point-of-Care system (optical analyser/centrifuge and accompanying micro-fluidic disposable cartridge) used to detect Liver Impairment (Class II IVD), a piezoelectric Point-of-Care system used for measuring Thyroid Stimulating Hormone Levels (Class II IVD), an automated sample Inoculator and fluorescent reader product line for PCR Plates (Class II IVD).• Helped develop the company’s internal process for carrying out product Risk Management in accordance with ISO 14971.• Assisted with improving the way in which the company managed design input via an improved product requirement traceability matrix, brining it more in line with ISO 15288.

• Provided technical assistance within the hardware/electronics team on various medical, diagnostic and analytical instrument development projects. • Built, tested, documented and repaired mechanical systems, Printed Circuit Boards and electrical wiring assemblies.• Assembled and tested products to manufacturing procedures on a number of finished projects including ongoing manufacture of ultra-wide field Scanning Laser Ophthalmoscopes used to obtain images of the Retina (Class II Medical Device), a PCR Plate temperature sealer (MET certified laboratory equipment), a Magnetic Sample Rotating Incubator (MET certified laboratory equipment).

• Managed the QA & QC team involved with all product life cycle stages of Automated ELISA Systems, including Electromechanical IVD Instrumentation, Assays, Certified Consumables & After Market Support Services.• Implemented the IVDR (EU 2017/746 regulation) into the QMS and product technical files for market approvals, working alongside the Regulatory Affairs team. Updated and ensured QMS SOP compliancy with ISO 13485:2016 and FDA 21 CFR part 820 (cGMP) at the operational activity level.• Defined and measured KPIs for both product and process performance, and introduced Continuous Improvement activities to improve MTBF and reliability, alongside process flow within the manufacturing operations, resulting in leaner processes.• Lead the Management Review meetings and FDA site inspections.