I joined Terumo BCT in Larne, NI, as part of a move from the United States to Northern Ireland. My position involved leading the process development for a contract manufacturing pharmaceutical product. I was responsible for installing, commissioning, and qualifying a multi-million-dollar bespoke, high volume (20M+ units annually) fully automated Form, Fill, Seal (FFS) machine to produce the IV solution products. • I worked closely with and directed my project team to ensure the design was manufactured at a high-volume scale and that we had the appropriate processes to monitor and interpret process shifts. I filled numerous roles in this position as the site was in the startup phase when I joined the team. • During my time in this role, we successfully recaptured over £900,000 of development costs. We restructured our contract manufacturing costing to protect the company’s bottom line due to design transfer delays, which amounted to over £7 million. • This role was offered to me by Terumo BCT due to my previous history with the company. I stepped in to offer my skills and experience; ultimately, the role did not fit my career goals, which is why I left for a role in new product development.

I was brought on to provide engineering services to pharmaceutical and medical device companies. These services include expert consultation on Design Controls, Requirements Management and traceability, risk management, QMS reviews, and guidance for developing combination and medical device products. • Conducts standards reviews and Design History File (DHF) gap assessments/remediation and risk documentation for combination products to ensure compliance with EU MDR and ISO 14971:2019. • Identify and implement continuous improvement opportunities within QMS areas to improve compliance and efficiency. • Maintained and updated quality documentation and records. Assisted with product risk review and post-market data review.• Develop risk management plans, hazard analyses, use FMEA, and design FMEA for new combination devices.

I was recruited to join Invitae as the second system engineer to build the team structure for design and development, usability engineering, and design transfer support for IVD products. Invitae had recently acquired the startup ArcherDx and their oncology Research and IVD technology. The company was in the stabilization and growth phase when I joined the team. • I led the systems engineering and human factors team in upgrading the company’s usability process to align with the requirements for IVDR compliance and BS EN 62366-1 integration. I helped spearhead the first gathering of usability research while working on the development and user experience of the Next Generation Sequencing (NGS) IVD device. • My team assisted in the corporate championing of Orcanos requirements management tool for Design History File traceability and Impact Assessment Management, which included: Integration of the requirements for the Personalized Cancer Monitoring™ IVD product that was entering the clinical trial phase as a companion diagnostic for cancer treatment therapies. We also provided direct support for the various core teams in the planning, requirements generation, system architecture, risk management file generation, usability file generation, verification, and validation of the IVDs in our portfolio. This work served as the basis for the future design transfer, regulatory submission, and commercialization of the IVD products. • I left Invitae to pursue an opportunity in Northern Ireland and elected to move there for the international experience.

• I provided systems engineering subject matter expertise to support the expanded registration of a therapeutic apheresis system in the China market. The approval increased access to Continuous Mononuclear Cell Collection procedures, Platelet Depletion Procedures, and White Blood Cell Depletion procedures. This project won the Patient Impact Award for Terumo BCT.• Responsible for systems engineering input across multiple new therapeutic product development and sustaining engineering projects that involved significant interaction with US-based and international cross-functional teams (product concept through launch and Post Market Surveillance activities). • Provided technical leadership on new product platform concepts and innovation, including electromechanical prototyping and design, d-FMEA and u-FMEA risk mitigation strategies, user needs and requirement generation, system architecture and traceability tool management, and protocol development to expand market penetration.• Outlined activities, scheduled and facilitated regular customer conference calls, internal progress meetings, and post-project reviews for clinical trial and product improvement initiatives; provided meeting notes and follow-up action items for all involved stakeholders. • Engage with the large cross-functional team to remediate the legacy therapeutic product DHF for MDR submission. Led the systems-level effort for verification, validation, and full product traceability to align with MDR requirements. • Advocate and champion user-centered design by providing specific market examples of successful product launches that involved the quick adoption of effective and successful medical devices globally.• Conduct data analysis of device complaint data and MAUDE data to identify improvements, plan user research activities, and collaborate with x-functional teams to prioritize design decisions related to usability and mitigation of use-related risks.

As the project lead, I helped a team of over 50 international associates successfully design transfer an automated whole blood processing product that increased market penetration throughout European, South American, and Middle Eastern countries. The new introduction reduced complaints by 82%, increased gross margin by 40%, and increased sales revenue by $8 million annually compared with its predecessor. The project received the Terumo Global Silver Award for this accomplishment.Created and identified new product requirements for various single-use disposable sets for blood collection and processing. Led the effort to design and release new disposable SKUs using the company's design controls process. Partnered closely with product management and operations to ensure smooth delivery of products and services using customer-backed studies and engagement surveys. Architects and executes formal verification and validation plans, including summative and formative human factors studies, use validations, and clinical trial support. Provides engineering expertise to develop test plans and Test Method Validations based on risk profile and impact assessment. Leads process development and validation efforts at a new manufacturing facility in Vietnam (specifically super-heated water sterilization, RF welding, tube and vinyl extrusion, assembly, solution mixing and filling processes for disposable sets). Provides technical support and analysis for manufacturing in Vietnam and Northern Ireland, assists in the closure of NCs, and suggests manufacturing improvements through analysis of existing NCs and CAPAs across the entire manufacturing area. Proactively identified opportunities for improvement and prioritized milestones to maximize value, reduce costs, and minimize redundancies at new manufacturing site in Vietnam. Experience initiating and closing CAPAs relating to manufacturing non-conformities using tools like DMAIC.