Lead a multi-discipline team of 16 in delivering projects across entire product lifecycle, from scoping to post market surveillance and sunsetting. Place focus on post-launch product changes to increase profitability, address quality and improve performance for mass produced electromechanical Fem-tech wearable connectable products. Developed and delivered holistic, risk sensitive, cross-department product change process incorporating innovation, production support, compliance matters, and reliability improvements. Drive continuous improvement initiatives to optimise performance, manage budget for in-market product development activities, and set up processes for change implementation to be compliant with ISO 13485:2016.• Led team of engineers in improving product reliability of Elvie Pump. Delivering 600% reduction in customer complaints for a mass production product (100K+ unit sales per annum, equating to £500K+ saving per annum). Helped to secure Series C funding as a result (£80M).• Delivered leadership across product development, verification and validation engineering and data science to develop the next generation of revolutionary products and product evolutions.• Successfully ensured continuation of mass production in the face of the global component shortage issue across entire product range. Worked with procurement, electronics, and finance teams to identify solutions to these challenges. Led product redesign and equivalence testing in compliance with ISO 13485. • Delivered 15 product redesign projects without incurring high cost of production stoppages.• Supported team in passing recent ISO 13485 audit, and delivered over 200 changes within three years across product range.• Gained promotion from Team Lead to Head of in 04/2022.

Provided SME oversight on mechanical engineering direction, design, development and issue resolution for new and existing instrument and consumable products. Led lean development of a revolutionary automated life science instrument and consumable to enhance drug discovery. Managed iterative design, prototyping, and testing through team coordination. Held additional responsibility for quality management for product hardware, delivering continuous improvement of infrastructure and processes; achieved significant quality improvements on consumable.• Delivered 25% cost reduction on existing Organ-on-Chip product instrument, as well as a 35% cost reduction on the associated consumable.• Played key role in development of a “beta” product for revolutionary organ-on-chip drug discovery system. Led consumable and instrument development based on early prototype. • Provided hands on design and development of several novel technologies, and owned product interfaces (electronics, software, bioengineering). Managed consultants to deliver instrument and industrial design on time and budget, whilst personally developing complex microfluidic consumable. Delivered technical strategy for transfer to mass production.• Instilled product development and design control process, including component and assembly design control, and BOM and other key document management.

Developing products at the forefront of the Organ-on-Chip market. Leading consumable and instrument development.

Led multi-disciplinary team that developed product-focused instrument prototypes for a highly complex integrated molecular IVD development to ISO 13485 standards (instrument interfaces with meso- / mirco-fluidic cartridge and includes pneumatics, fluidics, and precise temperature control). Managed subcontracting of projects to external engineering consultancies as well as line management of internal team of permanent and contract staff. Oversaw all aspects of the instrument development, including technical strategy, system architecture, interface management, budget management ($5M+), formal project schedules, managing risk registers, weekly reporting to senior management and presentation to company stakeholders.• Developed prototypes to successfully deliver major milestones to secure additional funding from BARDA.• Led development of several breadboard instruments and cartridges to enable rapid assay-on-chip iteration. Delivered necessary evidence of technology foundations (for sample-to-answer system) to secure third round of BARDA funding.• Directed team to ideate product design solutions which could address the complexity whilst also being grounded to what was viable from a manufacturing and cost perspective.

Oversaw eight-member team of cross-functional engineers in successful development two generations of prototype medical chip readers. Handled all aspects of requirements and specification management, timeline, and budget management across three departments, integrated technical solution identification, risk management, line management, and liaising with commercial activities. Led engineers to research and develop miniaturised technology, produce prototypes, establish assembly and testing protocols, develop user appropriate industrial designs, and improve rapid prototyping and use of simulation tools. Developed multilayer chips using SolidWorks, 2D/3D design of sheet metal, CNC machined, 3D printed produced parts, developed 3D modular assemblies, and developed assembly tools / fixtures.• Generated novel design solutions that provided the optimal interface between the biology, consumable and rest of the reader device. • Developed first and second generation of integrated instrument for a point-of-care diagnostic device (lab-on-chip), leading a team of multidisciplinary engineers covering optics, electronics, software, mechanics, and industrial design.• Developed and managed interfaces with cartridge and biology teams• Successfully demonstrated system integration helping to sustain further investment.• Designed and developed a novel precision dynamic cartridge location interface with locational accuracy to within 10 micrometres, integrating pneumatic and optical interfaces.

Specified, designed, and tested mechanical aspects of a new IVD product. Produced initial proof of principle device, ensuring adequate interfaces for low-cost consumable and biochemistry, including development of sub-assembly specifications, and third-party contractor management. Used SolidWorks to produce overall instrument design and part details drawings for manufacture.• Designed and developed integrated breadboard prototype instrument for an infectious disease diagnostics product. Successfully demonstrated assay-on-chip during laboratory trials, helping secure second stage of funding from BARDA to develop and integrated user facing device.• Developed low-cost novel fluorometric detection sub-system.

Served as Technical Lead for automated bioreactor mimic product (ambr250), with responsibility for delivering and engineering new product developments (including an early stage miniaturised perfusion system), key documentation, quality control, and implementing product cost savings. Owned overall responsibility for ensuring compliance with machine safety regulations.• Led development of over 60% of sub-assemblies of ambr250 during the product development phase, including a class two laminar flow cabinet, a liquid handling robot, and a sample plate freezer. Developed site installation method. • Successfully resolved over 50 issues in two-year period.• Drove cost reduction projects to improve margin; achieved 10% cost reduction.• Developing product enhancements to further the device offering and drive future sales, including two hardware enhancements and addition of one consumable line.

Structural health monitoring of wind turbine structures.Special focus on internal structural integrity of large blades (MW scale).