Colm Coffey, MSc

Leading AI architecture and engineering for EU medical research institutions and healthcare companies. Design and deploy production ML systems with focus on regulatory compliance (GDPR, EU MDR, FDA). Key Projects: - Production RAG Platform: Architected multi-tenant system on Azure processing 1000+ medical journals. Built with Kubernetes cluster orchestration, Qdrant vector database, Azure OpenAI integration, FastAPI microservices, PostgreSQL. Terraform IaC for reproducible deployments. Reduced research review time 60%. - Federated Learning Architecture: Designed cloud-agnostic ML infrastructure for multi-site clinical data (HERVOMIND consortium with Herevolution Pharma). Enabled GDPR-compliant collaborative model training across hospital networks without data centralization. Terraform + Kubernetes deployment. - EU Research Consortiums (€1.4M+ budgets): Lead AI architect for Parkinson's digital twin platform (Turku University), oncology clinical trial system (HE-Arc), precision medicine initiatives. Designed GenAI architectures with regulatory compliance built-in. - Enterprise ML Solution: Architected inventory optimization and forecasting system for Johnson & Johnson DePuy (EMEA). Predictive analytics for €1B inventory with projected €16-19M annual savings through demand forecasting. Technologies: AWS (Bedrock, Lambda, SageMaker, EC2), Azure (OpenAI, AKS), Terraform, Kubernetes, Docker, Python, FastAPI, PostgreSQL, Qdrant, LangChain, TensorFlow, PyTorch, MLOps, CI/CD

Contract position as Solutions Architect at Irdeto, I leverage my extensive experience in medical device engineering and product management to drive innovation and growth in the healthcare sector. I specialize in cultivating business relationships, adapting Irdeto's technology for use by medical device companies, and demonstrating the value of our solutions through engaging presentations and demos. My key responsibilities include: - Developing and maintaining strong relationships with clients and partners in the medical device industry - Adapting Irdeto's technology, such as License Management, Keys & Credentials, and Vunerability Management, to address the unique needs of medical device companies - Collaborating with cross-functional teams to design and implement tailor-made solutions for our clients - Presenting compelling product demonstrations that showcase the capabilities and benefits of Irdeto's technology in the healthcare space - Identifying new market opportunities and trends to ensure our offerings remain competitive and aligned with industry demands By combining my passion for healthcare and engineering, I strive to tackle some of the medical industry's most pressing challenges, ultimately improving patient outcomes and driving the digital transformation of healthcare.

Project Engineer managing team to implement design changes to the PB980 ventilator - Project lead in Design Change projects (CDP Projects) for ventilators - Design and arrange manufacture of ventilator components - Prototype and testing of replacement components - Approve design technical specifications of new supplier parts - Verification and Validation documentation for labelling compliance

I believe mentoring the next generation of engineers to be one of the most important and fulfilling roles one can take in this field. Upon the completion of my Master's Thesis, I took on a temporary role with Ireland's Centre for Talented Youth. Responsibilities: Teaching transition year students (Aged 15/16) about Electronic Engineering. My course covered content relevant to first and second year of University while also giving students an opportunity to introduce basic concepts of engineering and to creatively explore real life challenges. Projects included 3D printed drones, solid state batteries, quantum computing among others.

After a year of rolling shutdowns, waiting lists have been a giant elephant in the room for the healthcare industry. SmoothOp is clever software application that helps Operating Theatres work more efficiently. Principles borrowed from lean manufacturing help to increase visibility and eliminate wasted time between procedures. This tool is being developed alongside frontline staff to reduce stress enhance their day and where possible.

As part of my US graduate visa program, I was required to take on an internship. Dropping into Start-Up events was a great was to learn about MedTech innovation. This is how I found out about ClinCapture's vision of paperless clinical trials through Electronic Data Capture. I called into the CEO, and together with the engineering team worked out a position for me to contribute what I've learned in AI and automation to the mission. The role ended as circumstances surrounding the coronavirus pandemic compelled me to return to Ireland where I decided to pursue a Masters in Medical Device Design. Responsibilities: Executed FDA PQ validation for latest software update of clinical EDC. Troubleshooted issues relating to new software release. Developed an automated software testing protocol to achieve streamlined PQ validation.

In this role, I applied learned in my diploma for Operations Management to construction in the US. This included quantitative methods to predict the cost and revenue of jobs, as well as opportunities to manage project teams on the ground. The role ended as circumstances surrounding the coronavirus pandemic compelled me to return to Ireland where I decided to pursue a Masters in Medical Device Design. Responsibilities: Planned, designed and managed various kinds of engineering projects. Estimated quantities and costs of labor and materials. Transcribed estimations for large scale projects. Created excel spreadsheet to automate estimations where applicable. Reduced labor and costs by planning and implementing continuous improvement programs. Liaised with architects and other construction professionals. Reviewed all plans, documents and calculations for steel construction.

Prior PLM Medical is a small medical device design and manufacturing company. This family run business operates similarly to the famous 'Mittelstand' model. Prior PLM medical utilizes its small scale and specialized expertise to quickly implement DFM innovation on behalf of its large customers. These include Boston Scientific, Medtronic, Abbott, and Johnson & Johnson. Medical device consulting for human-centered design Development of concepts, detail design, testing and refinement Scale-up Design for Manufacture 3D modelling using Siemens Solid Edge CAD Coordinate the design team with end-users, university researcher team and physicians Products I worked on included an Exoskeleton, Injector Pen, Breath-Actuated Inhaler, and Pacemaker Compliance of FDA, EMA, ISO 13485, and ISO 9000 regulations Data analysis using MS Excel and Minitab

Site Servcies for manufacturer of injector pens and drug delivery cassettes Resolve issues with facility SEUs (Air Handling Units and Chilled Water System) Organise scheduling and coordinate 42 site upgrade projects Continuous improvement of GMP clean-room environment and standard protocols Green Belt Project delivering 70,000 Euro ($78,500 equivalent) in annual savings Acquirement of 230,000 ($258,000 equivalent) cumulatively in EU and federal grants

As part of my undergraduate degree, I was required to take on a 6 month internship. On behalf of Engineers Without Borders Ireland, I was selected to take on a initiative in village sanitation driven by UNICEF and the EU Sphere Project. Responsibilities Construction of basic sanitary facilities (bathing, hand-washing, and pit latrines) Implementing best practices for daily hygiene and facility construction Continued representation of EWB Ireland conducting presentations nationwide Accrued 3,000 Euro in fundraising activities to fund travel

12 month intensive degree program focusing on product development, software development, academic research, and group work projects within scope of medical device development.

I received a comprehensive education in Engineering systems and practices over four years. The first two years concentrated on solid and fluid mechanics, mechanical systems, and material science. In the final two years, I built upon this foundation, applying it to projects in the biomedical field. This included work on image analysis and object detection, along with studies in regulatory compliance and business models like product development and operations research.