As a Programme Manager within the Medical Technology Division, I undertake the development of innovative new medical devices and systems from concept, through prototype manufacture, to new product introduction, often surmounting considerable technical challenges. I undertake development projects across a whole spectrum of domains including drug delivery systems, surgical products and systems, diagnostic instrumentation, and digital health platforms. I lead the delivery of novel and radical solutions to new and existing problems under tough commercial, regulatory and time constraints.My specific responsibilities include:- Management of projects from the proposal stage through to the delivery of the project- Manage multi-discipline teams from both the UK and US offices- Liaising directly with clients to understand their programme needs for a broad range of projects including large diagnostic and life sciences instrument development, drug delivery device development programmes and surgical device developments- Estimating timeline, resource, budget and key technical risks for proposal preparation- Building and managing the project team with the appropriate level of expertise for the proposed work- Reporting technical and financial progress both to the client and internally- Lead meetings with clients, present and communicate ideas and concepts to all disciplines- Take the lead in ensuring that projects are run to relevant quality standards including the EU and FDA standards for medical devices and in-vitro diagnostic equipment- Take the lead in ensuring that projects meet appropriate safety standardsI also support the business development functions, exhibiting and presenting at key conferences and at sales meetings.

In my current role I lead the development of parenteral drug delivery systems (devices and combination products) within the Technical R&D department, from early phase activities up to commercialization and production scale up. My responsibilities include detailed project planning and monitoring of requirements/deliverables, timelines, costs, people and other resources, plus stakeholder management. I am responsible for the design plan and completion of stage reviews as required by company procedures. The project teams I lead consist of experts in: device technology, primary packaging, human factors, risk management, analytics & testing, as well as a manufacturing and commercialization function. I am accountable for the delivery of project outputs by team members. The team operates within a matrix organisation whereby project leaders influence without authority to deliver each project within agreed targets. I am the direct interface with internal customers and present project progress to senior customer and line function committees. I manage multiple projects, principally within the subcutaneous and ophthalmic drug delivery areas. I am responsible for procuring and managing services of 3rd party vendors such as design consultancies, formative and summative user studies, contract manufacturers, and metrology/testing services. In addition to leading projects I also contribute to the project management excellence program and the development of new tools and processes. I support the hiring of new associates across multiple device groups and mentor new starters. I undertake regular training which has included PMP.

In this role I led the development of parenteral drug delivery systems (devices and combination products) within the Biologics Technology Development and Manufacturing department, from early phase activities up to commercialization and production scale up.

It is the responsibility of the Design Engineering team to evolve design concepts such that product requirements are met and reliable product performance due to design is assured. As leader of the Design Engineering team my responsibilities include: - Approval of technical specifications. - Compilation of procedures, guidelines and work instructions.- Team management (guidance, support, project resourcing, one-to-ones, appraisals, etc.).- Project planning and quotation. The Design Engineering team sits within the Product Delivery group whose goal is to develop product designs which fulfil the functional and quality requirements of our customers, end users and regulatory authorities, in a timely and cost effective manner.

My current role is principle engineer for a multinational OEM customer. My role is to deliver a detailed design concept for a disposable auto-injector device. Current duties involve: managing client relationship, presenting to clients, project planning and resourcing, managing external contract resources, outsourcing and managing design analysis activities and prototyping, and coordinating Design for Manufacture feedback. I have conducted platform technology research, invented patentable technology, and contributed to robust procedure development to compliment (and in addition to) direct project activities.

Cellnovo Ltd is a start up company developing a next generation insulin pump for Diabetics. I started on an initial 3 month contract. My role centred on assessment and development of manufacturing stations for the assembly process, both from review and optimisation of current processes, and development of entirely new assembly methods.. I was responsible for procurement and outsourcing of bespoke equipment manufacture. Secondly, I was responsible for co-ordination of all mechanical testing to ensure the product meets regulatory and company quality standards. This spanned the full spectrum of testing from functional component, sub assembly, manufacture build, and final product testing. This involved test identification, prioritising, procedure development and progress monitoring. 11 months total employment with Cellnovo.

Cambridge Design Partnership LLP. is a product development consultancy firm. I was involved in wide range of projects across the medical and consumer product sectors. Key skills required were the ability to work both in groups, and autonomously, manage projects, budgets, and teams, and report to clients. My responsibilities included delivering test data, working prototypes and intellectual property for my clients. My work included initial concept development, existing patent review, test rig development and commissioning, sub-assembly and final product testing, fault detection (specialist in high speed video), and production line development.