Leeds, England, United Kingdom
I am passionate about ensuring that every patient receives the best possible medical care and I am enthusiastic about furthering my career into the ever-evolving technologies facilitating new material solutions, patient specific interventions and custom medical devices. I have a PhD in Medical Engineering and 3+ years industry experience in Medical Devices I'm currently a Quality Engineer at Axis Spine Technologies, working with a team of experts to deliver pioneering Anterior Lumbar Interbody Fusion (ALIF) technology to the US market In March 2023 I passed my PhD, completing an EPSRC industry CASE funded PhD with DePuy Synthes at the University of Leeds where I developed a combined experimental and computational approach (using ABAQUS) to investigate the wear impact of patient specific alignment on total knee replacements. I also have a Green Belt in Lean Six Sigma and have a keen interest in Lean principles.
Core R&D team member within a start-up, developing a pioneering anterior lumbar interbody fusion implant system. Leading on quality related projects focussed on V&V, design controls, DHF documentation, DMR documentation, inspection control, supplier quality, NCs, CAPAs, complaints, change controls, equipment management and continuous improvement of the QMS (ISO 13485 & FDA 21 CFR 820) Experience in FDA inspections and supplier audits. ISO 13485:2026 Internal Auditor certified.
- Writing design inputs, outputs and user requirement specifications including V&V activities for medical devices for Neuraxial applications in accordance with ISO80369-6, ISO 7886-1 and other applicable standards - Writing dFMEA's for Neuraxial devices - Writing Risk management documentation in accordance with ISO14971 - Maintaining and reviewing DHF documents through conducting gap analysis for Neuraxial Devices and Wound drainage devices to ensure compliance to the applicable international standards. - Ensuring DHF compliance with the quality management system and ISO 13485 - Communicating with external suppliers to keep DHF up to date - Raising and actioning change controls - Maintaining up to date information on the UDI database (1WorldSync) - Working as part of a cross-functional team with NPD, Quality, Regulatory Affairs, Exports, Design and Sales Teams
- Reviewing and updating documentation for Class Is/m, IIa and IIb to ensure readiness for MDR 2017/745 submission - In depth research and learnings of the Medical Device Directive 93/42/EEC and Medical Device Regulation (EU) 2017/745 - Maintaining technical files for Class I devices in accordance with MDR 2017/745 - Maintaining technical files of Class Is/m, IIa and IIb and higher in accordance with MDD 93/42/EEC - Collating documentation for international tenders - Writing procedures and creating templates for ensuring compliance with global standards and MDCG guidelines and implementing document control in accordance with ISO 13485 - Conducting Gap analysis on product compliance with appropriate global standards - Communicating with external suppliers to keep Technical files up to date - Raising and actioning change controls - Maintaining up to date information on the UDI database (1WorldSync) - Working as part of a cross-functional team with NPD, Quality and R&D, Exports and Design
Assisting undergraduates with their testing of materials using an Instron (bluehill 2 and bluehill 3) for tensile tests and 3-point bending tests. Giving initial demonstration and safety information for the lab and providing further guidance to students throughout the laboratory session. Marking laboratory reports submitted in accordance with the module assessment marking criteria and providing written feedback to students.
Working to engage secondary school students in STEM subjects and promote higher education to students from statistically underrepresented backgrounds. Create and provide workshops to classes of students aged 11-18 that are interactive, fun and educational, fitting into their school curriculum and adapting sessions to be online and still engaging during the COVID-19 pandemic. Attending science fairs and after school clubs to deliver sessions to a larger outreach of students. Giving guidance to new outreach fellows on how to develop and deliver sessions.
Undertook a short research position to initialise preliminary testing for a project aimed at understanding skin adhesion properties of different Ostomy product materials. Developed a protocol combining methods from ISO 12505-2:2016, ISO 11339:2010 and F2256-05(2015) for testing different adhesive materials on porcine skin. Completed the preliminary testing on a Biomomentum Mach1 where a T-peel test was used on different adhesive materials to determine their adhesive strength.