EDWARD MCQUILLAN

Coating Crosslinker Material Equivalency

• Global Lead R&D Engineer for the material equivalency study involving 26 Boston Scientific products across 4 different divisions.
• Conducted FT-IR and GC-MS testing to assess the chemical compositions of the current and proposed materials.
• Results compiled within an extensive technical report, conclusively proving material interchangeability. This avoided the need to reconduct global Design Verification testing across the 26 products impacted and ensuring the protection of $25 million annual revenue for PI.

Carotid Wallstent Technology Development

• Subject Matter Expert (SME) for Carotid Wallstent, a transcatheter self-expanding stent delivery system indicated for the carotid arteries.
• Served as the R&D lead when tasked with executing strategic design changes to optimise production capacity, ensuring continuity of projected sales growth and market expansion.
• Worked closely with Design Quality Assurance, Manufacturing and Quality Engineering to generate a design solution to safely accommodate a 25% increase in units per hour.
• Collaborated with KOLs and Medical Safety in support of NCEP activities to justify non-containment.

Express LD Balloon Development Technical Design Phase

• Development of a next-generation Express LD system to integrate a modern balloon design for improved usability. User studies conducted for relevant design considerations.
• Coordination of ~1000 finished good special request builds to determine proof of concepts. These will be assessed within a design matrix to form a final design concept for the product development process (PDP) phase.

• Development of a new audit tool for 4 existing peripheral interventional products.
• These Design Verification Summaries outlined all design requirement specifications, associated risk indices, sampling plans and DV results within an easy-to-read document to streamline responses in support of EU MDR.
• Investigation lead for CAPA activities in support of an identified non-conformance.
• Supported the creation of a new Global DFMEA document for a self-expanding stent delivery system.

• Company Overview: University of Galway
• Conceptualization of a novel procedure to treat carotid artery stenosis for the prevention of ischemic/ embolic stroke.
• Conducted extensive market research to determine a problem statement within the current standard of care.
• Built strong relationships with experienced vascular surgeons/ KOLs within the carotid artery disease space. This involved 1:1 interviews to gain an insight into procedural limitations, ensuring needs-driven innovation.
• Incorporated a Customer Centered Design solution leveraging Boston Scientific's existing device technologies while aligning with the division's progressional goals within the carotid artery disease market.
• Presented elevator pitches to multiple director-level stakeholder groups within the PI division, earning exploratory funding and crediting the idea with a 2024 PI Innovation Award.
• University of Galway

• Delivered tailored presentations and educational material on BSC products to over 500 students across more than 20 schools nationwide, inspiring the next generation of engineers.