Currently:• I lead a multidisciplinary team, consisting of the CAD, technical documentation and technician functions, enabling projects to successfully progress through to the development and launch milestones.• I ensure the timely and successful ramp-up of new products by developing and implementing stable and repeatable manufacturing processes and by collaborating with design teams, suppliers and production.My focuses are:• Ensuring projects have the appropriate level of support function, including prototype building, CAD and build implementation, through the planning and resourcing of the technical services stream according to business priorities.• Leading projects through the product development pipeline from project approval, to product development completion and successful production line implementation and transfer. • Defining and executing on manufacturing requirements, including plans for process development, validation, pilot line setup and implementation.

I was responsible for the timely and successful introduction and ramp-up of new products by developing and implementing robust and repeatable manufacturing processes. My focuses were:• Developing manufacturing processes through the stages of proof of concept, optimisation, validation, implementation and realisation. • Reviewing product designs for manufacturability and volume production including developing manufacturing process and validation strategies.• Collaborating with stakeholders to develop equipment and process capabilities, and support integration.• Planning and executing the qualification and validation (IQ, OQ, PQ) of new process by means of change point analysis, risk management (hazards analysis, PFMEA) and risk control implementation.• Design transfer into manufacturing including the rollout of process documentation (GMP documentation and process developmental histories), training teams and Production hand-over.• Ensuring readiness of Production lines by planning and line auditing of infrastructures, equipment and services.• Leading and managing manufacturing builds (process characterisation, design verification, pilot production and performance qualification volume manufacture) to satisfy all product-testing requirements.Achievements:• End to end development of a custom silicone injection moulding system, from proof to concept to implementation and successful Production ramp up, realising an $850,000/year cost saving.• Affected a 4% process yield improvement through the successful root cause analysis and recommendation of improvements to current Production processes.

I was responsible for the project planning, validation and introduction of manufacturing processes within the new manufacturing facility. My focuses were:• Leading risk management meetings with design, quality, production and validation stakeholders to develop and revise Process Failures Modes and Effects Analysis (PFMEAs).• Reviewing operational activities and technical documentation for compliance to requirements and process capability.• Effecting the rollout of the introduced validation procedure by developing and spearheading a working model.• Developing and executing validation strategies, protocols and reports (IQ, OQ and TMV) according to quality and compliance requirements. • Establishing and implementing operating documentation including product specifications, standards, work procedures and test methods. • Liaising with external vendors to develop and procure equipment according to product requirements.• Providing technical support with the identification, investigation and resolution of process deviations. Achievements:• Successfully introduced manufacturing processes within new facility, currently operational at full volume capacity.• Conducted training workshops and was nominated as the first point of contact for validation implementation.• Optimised acceptance testing processes, achieving a 15% increase in yield and improved product compliance.

I was responsible for the root cause investigation and reporting of field returned products. My focuses were:• Developing analysis reports through the investigative evaluation of field returned devices used as product reliability feedback to design, production, clinical and regulatory stakeholders. • Liaising with senior engineers to develop and implement streamlined and improved analysis processes.Achievements:• Led a team of 5, successfully planning and facilitating the investigative and analysis reporting processes to resolve cases with an increased efficiency of 30%, significantly exceeding timeliness of case resolution.

I was responsible for liaising between engineering and manufacturing production to bring a new product model to market. My focuses were:• Interfacing between production, design and managerial stakeholders to facilitate an effective design transfer into manufacturing.• Demonstrating design feasibility by performing prototype verification building.• Establishing manufacturing line processes by implementing quality documentation, training process workers and setting up of just-in-time systems.Achievements:• Co-ordinated new product introduction for both national and global markets meeting initial Market demands.