Simon M. Email & Phone Number

Adelaide, South Australia, Australia

Adelaide, South Australia, Australia

As a principal engineer, I have the privilege of providing guidance and mentorship to both junior and senior engineers within various projects. My role involves leading the design, drafting, manufacturing, and testing of prototype parts and assemblies, leveraging technologies such as 3D printing (FDM, SLA, SLS), CNC machining, and sheet metal bending to achieve project objectives.Throughout my professional journey, I have prioritised precision in performing detailed mechanical design specifications, including simulation, and verification testing. This meticulous approach reflects my dedication to delivering engineering solutions of the highest quality when required.Collaboration has been a cornerstone of my work, as I have collaborated closely with Project Managers and team members to ensure project requirements are met in alignment with organisational goals. I am adept at identifying and addressing scope and schedule risks, working diligently to mitigate potential challenges and ensure project success.Additionally, I have played an integral role in preparing comprehensive design data packs, ensuring that all documentation meets rigorous standards and supports efficient project execution. My commitment to maintaining meticulous documentation standards reflects my dedication to excellence in my work.In pursuit of continuous improvement, I am currently leading initiatives to propose, plan, and implement design and process improvements in collaboration with fellow team members. These efforts have aimed to enhance quality, reduce costs, and improve safety & efficiency, underscoring my dedication to driving innovation within the engineering field.In terms of achievements, I have had the privilege of contributing to the successful design of an x-ray high voltage generator in partnership with a large global medical device company. Currently, I am leading the engineering support for the Rover Mobile DR x-ray units, committing to continuous improvement efforts.

Sydney, New South Wales, Australia

In the role as a lead engineer, I was entrusted with providing engineering leadership to both Production Engineer and Quality Engineer counterparts, guided them towards the common objective of securing regulatory approval for The Kunovus Disc Device.I supported and mentored my team members, ensuring they are equipped with the necessary knowledge and resources to contribute effectively to our shared goal. Additionally, I collaborated closely with the Manufacturing Manager to drive continuous improvement initiatives aimed at enhancing product quality, reliability, and manufacturability. We worked together to identify areas for improvement and implement strategies to address them. Such as implementing a suitable desktop autoclave for product sterilisation purposes and, facilitated the purchase of a mechanical CAD software to improve design and manufacturing process efficiencies.The team worked to establish a clear roadmap to facilitate the ongoing TGA approval process for The Kunovus Disc Device. With focus on thorough planning and strategic resource allocation, we were able to identify the existing gaps and took the necessary steps required to advance the existing body of work towards the approval process.

Sydney, New South Wales, Australia

As a senior engineer, I provided crucial engineering support for both existing and new products, ensuring timely delivery to market while upholding stringent quality and cost standards.Collaborating closely with the manufacturing team, I actively seek opportunities to enhance product quality, reliability, and manufacturability, driving continuous improvement initiatives throughout the production process.With focus on effective project management, I led and oversaw engineering change notes (ECNs) for sustaining engineering projects, ensuring adherence to design controls, established timelines, and stakeholder satisfaction. I took approaches to identifying and managing third-party experts, leveraging key design partners and suppliers to develop specific process elements essential to project success.I was involved in generating and maintaining comprehensive manufacturing documentation in compliance with ISO13485 and FDA QSR standards, including risk assessments such as DFMEA and PFMEA. Furthermore, I leveraged my expertise in jigs & fixtures design to optimise production assembly methods and facilitated continuous design and process changes.Collaborating closely with the Procurement and Supply Chain teams, I assisted in part costs and volume determination with suppliers, ensuring the most cost-effective solution. Additionally, I oversaw first article inspection and sample approval in collaboration with the Quality team, managing the technical aspects of quality control activities throughout the production lifecycle.In the event of non-conformances, I assisted thorough investigations using established problem-solving processes, including tools such as the 5 Whys, Cause & Effect analysis, and the Kepner-Tregoe method, to identify root causes and implement effective corrective actions.Through my comprehensive approach to engineering support and project management, I am committed to continuous improvement in all aspects of product development and manufacturing.

Sydney, New South Wales, Australia

In the role as a senior engineer and project manager, I engaged in collaborative brainstorming sessions to conceptualise new products or enhancements for a diverse range of sales channels, including supermarkets, pharmacies, dentists, and hygienists. With a focus on meticulous requirements generation, I developed comprehensive test plans, protocols, and reports to ensure the viability and success of each project.Utilising advanced 3D prototyping techniques, I conducted thorough testing to evaluate concepts and establish feasibility, guiding the detailed design of product and packaging components. Leveraging my expertise in mechanical CAD design, I generated precise 2D drawings and 3D files for prototyping through to final production, ensuring adherence to rigorous quality standards throughout the process.Additionally, I managed supplier relationships in Asia, collaborated closely with manufacturers in regions such as China, Taiwan, and India to ensure seamless project execution and product delivery.Drawing on my strategic acumen, I assisted in pricing and costing projects and products, working collaboratively with cross-functional teams to achieve cost-effective solutions. I also served as a liaison with the Customer Service Department, addressing product inquiries and complaints when required.In terms of achievements, I successfully project-managed the development of the company's first oral irrigator product (Hydropik®), oversaw its journey from concept to production. Additionally, I spearheaded the development of the company's first orthodontic product for teeth alignment, guiding it through the stages of concept development to product demonstration with success.

Sydney, New South Wales, Australia

In my capacity as a senior engineer, I oversaw the management of engineering change requests and projects, ensuring adherence to appropriate design controls and timelines. I led product and packaging design initiatives, conducted comprehensive testing and validation to guarantee product integrity and performance.A key aspect of my role involved requirements generation and the development of test plans, protocols, and reports to guide project execution and evaluation. Additionally, I used my expertise to design jigs, and assembly aids tailored to testing and production needs, optimising efficiency, and precision throughout the manufacturing process.Furthermore, I was responsible for the generation of production documents, including material specifications, drawings, process flow diagrams, work instructions, BOMs, and batch records, ensuring clarity and accuracy in manufacturing processes.An area of focus in my role involved the enhancement of catheter assembly processes and equipment, such as curing ovens and light-cure adhesive systems, driving continuous improvement initiatives to optimise efficiency and quality standards.In terms of achievements, I successfully completed a major engineering change request, oversaw the establishment of appropriate component to finished product marking and labelling processes, including the implementation of an in-house laser marking system. Additionally, I played a pivotal role in establishing an automated QC process utilising an optical metrology system (Micro-Vu Vertex), enhancing efficiency and precision for the component inspection process.

Sydney, New South Wales, Australia

As a Validation Engineer within the Supply & Manufacturing Division, my primary responsibility was to ensure that all critical systems, processes, and equipment were set up and validated in alignment with both regulatory and corporate standards. This encompassed new installations, revalidation requirements, continuous improvements, and corrective and preventive actions (CAPAs).I was tasked with writing and developing validation protocols and reports for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ) activities, for new capital projects and revalidation efforts. These documents were crafted to meet the rigorous demands of established testing plans. Additionally, I performed data analysis to assess process capability and recommend necessary improvements.As the subject matter expert for leak detection systems, I provided essential technical support and guidance, ensuring optimal operation and reliability. I coordinated with project and production staff to align activities and schedules with business objectives, leading validation testing programs and effectively communicating validation processes, procedures, and timelines to enhance understanding and compliance across departments.Among my key achievements, I was part of a team that successfully managed the setup and validation of eight new finishing and packaging lines as part of a $120 million expansion project for Pulmicort Respules™. I also played a role in a company-wide packaging reduction project, which was projected to save $1 million annually. Additionally, I was involved in the validation of a leak detector replacement project, significantly improving line efficiency, and contributing to the company’s operational excellence.

Brisbane, Queensland, Australia

As a Project Engineer, I successfully assisted the management of an integrated pathology system, ensuring that it not only met design intent but also aligned with customer requirements.My role involved conducting detailed risk analyses in compliance with ISO 14971 standards to address high-risk or high-impact exceptions, facilitating effective issue resolution throughout the project lifecycle. I worked closely with design engineers to expedite product development cycles through rapid learning processes, simultaneously overseeing the resolution of system bugs and issues to enhance product functionality and reliability.I provided project leadership by effectively coordinating tasks and deliverables among design engineers, ensuring all project components progressed seamlessly from conception through to completion. My commitment to project management and proactive team collaboration led to the eventual successful completion and production release of a critical pathology automation project.

Brisbane, Queensland, Australia

My role as a Process & Quality Engineer involved close collaboration with electricians, welders, and design engineers to generate comprehensive production documentation, including work instructions, process flowcharts, visual quality specifications, and manufacturing data packs. I took responsibility for ensuring that all critical equipment was properly calibrated and maintained, with robust calibration records to uphold quality standards.My achievements in this role include the creation of the first set of work procedures and documented processes for the production of power storage systems. This initiative was pivotal in establishing a foundation of manufacturing knowledge that significantly enhanced product quality and productivity within the company. Furthermore, I played a key role in the development and implementation of a centralised documentation control and review system using Microsoft SharePoint, which streamlined data access and improved version control for manufacturing documents. Additionally, I provided mentorship and technical guidance to a junior Quality Assurance Engineer, fostering skill development and aligning her efforts with the team’s objectives.

Sydney, New South Wales, Australia

As an experienced Mechanical Engineer, my responsibilities encompassed product design, performing characterisation testing, design verification & validation activities, and fault analysis to ensure products met their intended specifications. I supervised and trained engineers and technicians in characterisation and verification testing activities. As well as spearheaded planning and execution of characterisation, verification, and reliability testing, while also carrying out comprehensive failure analyses to ascertain root causes to guide design improvements.I actively participated in design analyses, including stress prediction and Failure Mode Effects Analysis (FMEA), identified reliability concerns and potential safety hazards to define necessary controls. My role also involved coordinating safety and functional testing with compliance laboratories such as Vipac and TestSafe, underscoring my capability to manage external partnerships effectively. Additionally, I was responsible for setting up and managing an in-house mechanical testing laboratory.My achievements in this role include leading mechanical verification and validation (V&V) activities, developed testing matrices and Gantt charts to efficiently manage testing activities and resources on multiple projects. I also designed, set up, and managed the mechanical fabrication and testing laboratory for our product development group. This included the implementation of a range of specialised equipment such as an environmental chamber, a light microscope with image capture capabilities, a 3D scanner, a dynamic mechanical testing machine for cyclic testing of parts and assemblies, a thermal shock chamber for accelerated testing, and water ingress protection test rigs. These contributions significantly enhanced product development capabilities and quality assurance processes.

Sydney, New South Wales, Australia

In my brief role as a Production Engineer, I provided process engineering support to the senior microbiologist in validating the Ethylene Oxide sterilisation system. This encompassed the creation of detailed process flowcharts delineating each step of the sterilisation process, as well as overseeing the meticulous management of data logging throughout sterilisation cycles. Leveraging my analytical skills, I conducted thorough data analysis to supply validation reports with graphical representations and quantitative evidence, ensuring comprehensive documentation of the validation process.A notable achievement during my tenure was the successful completion of the ethylene oxide steriliser validation within the scheduled timeframe, in preparation for a planned FDA audit. This accomplishment demonstrated my commitment to upholding regulatory compliance and quality standards.

Sydney, New South Wales, Australia

In my role as a Mechanical Engineer, I engaged in sustaining engineering initiatives encompassing product design, supplier selection, feasibility testing, and verification & validation testing. This multifaceted responsibility involved performing feasibility testing on prototype samples, such as percutaneous leads, and collaborating with external testing laboratories such as Vipac Engineers & Scientists Limited to ensure alignment with test goals and requirements. Additionally, I was involved in conducting verification & validation testing on critical components such as the blood pump and its associated accessories.A key aspect of my role involved designing and sourcing testing apparatus, a task that requires close coordination with internal workshop staff to facilitate fixture design and manufacture. Using mechanical testing systems like the Instron tester, I conducted meticulous tensile and compression destructive testing to evaluate product performance and durability. Furthermore, I utilised optical microscopy and imaging software to detect and analyse defects, ensuring adherence to stringent quality standards throughout the development process.One of my notable achievements includes the successful redesign and improvement of a heart corer surgical tool, to meet clinical requirements. This endeavour underscores my commitment to innovation and customer satisfaction, as well as my ability to translate feedback into actionable design enhancements.

Sydney, Australia

I specialised in conducting comprehensive verification testing of motorised flow generators, focusing on the evaluation of various components such as motors, blowers, and flow generator prototypes. This involved assessing blower flow performance and efficiency, analysing machine and motor noise emissions, conducting vibration analysis, and evaluating heat transfer from heaters and humidification systems. I was extensively involved in environmental testing across different product phases, from prototype components and assemblies to fully manufactured machines. Collaborating with external testing laboratories such as Vipac Engineers & Scientists Limited and TestSafe Australia was required for test certification.A significant aspect of my role entailed designing and sourcing testing apparatus, where I liaise closely with internal workshop staff to facilitate fixture design and manufacture. Leveraging advanced mechanical testing systems such as the Instron tester, I conducted thorough tensile & compression destructive testing to assess product durability and performance. Additionally, I utilised environmental chambers for high & low-temperature conditioning testing and employed optical microscopy and imaging software for precise defects detection. Furthermore, I actively engaged with suppliers to procure prototype samples and collaborate on packaging design initiatives to enhance product presentation and functionality.One of my notable achievements include the successful design and construction of test apparatus aimed at improving the efficiency of early prototype CPAP humidifiers. This initiative underscores my proactive approach to process optimisation. Additionally, I made significant contributions to designing noise testing apparatus aimed at optimising product design concepts, demonstrated my commitment to driving continuous improvement and innovation in engineering processes.

Sydney, Australia

I was dedicated to developing manufacturing processes and implementing design enhancements aimed at improving product performance, safety, and quality. This involved investigating new bonding methods and optimising assembly equipment to enhance overall product functionality. Additionally, I contributed to the design and development of new products, fostering collaboration between production, quality assurance, regulatory affairs, and marketing departments to ensure alignment with organisational objectives.A key aspect of my responsibilities included the creation and revision of documents pertaining to production and New Product Development processes, such as Standard Operating Procedures (SOPs) and product specifications. Furthermore, I played a pivotal role in the modification and design of production machinery, tools, and equipment to optimise manufacturing efficiency and output. I also lend my expertise to plastics formulation and molding processes within the production environment, encompassing extrusion, injection molding, and blow molding techniques.An important initiative I spearheaded was the implementation of a standardised barcoding system for the company's products, streamlining inventory management and enhancing operational efficiency. Additionally, I served as an OHS representative for the production department and ensuring compliance with relevant regulations. Moreover, I organise social events such as lunchtime table tennis competitions to foster a positive work culture and promote camaraderie among factory workers and office staff.As part of my achievements, I successfully created and managed the company's Technical Drawing System, ensuring the controlled and up-to-date management of engineering drawings. Furthermore, I oversaw production lines in cleanrooms to guarantee that parts are manufactured to specification, contributing to the overall quality and reliability of our products.

Bachelor Of Engineering (Be), Mechanical Engineering

Activities and Societies: UNSW Tennis Club

Master Of Biomedical Engineering (Mbiomede), Biomedical Engineering