Experience

Optellum

• United Kingdom
• Medical Equipment Manufacturing
• 1 - 100 Employee

• RA/QA Manager - Software as a Medical Device

  • Nov 2019 - Present

  - Successful FDA 510(k), EU MDR class IIb (CE marking) and UKCA marking for software medical device (SaMD) with artificial intelligence/machine learning computer aided diagnosis (CADx). - ISO 13485:2016 and EU MDR Quality Management System implementation and maintenance.- Quality management representative. - EU MDR person responsible for regulatory compliance (PRRC).- HIPAA compliance officer.- Internal and external (notified/approved body) audits.

• Test and QA Engineer

  • Aug 2018 - Nov 2019

  - Initiated Agile software development compliance with quality management (ISO 13485), risk management (ISO 14971), software design and development (IEC 62304), usability engineering (IEC 62366) and cybersecurity standards.- Selenium with Scala automated testing.



Mirada Medical

• United Kingdom
• Software Development
• 1 - 100 Employee

• Senior Product Analyst/Test Engineer - Software as a Medical Device

  • Oct 2014 - Aug 2018

  - Led requirements gathering, use case to system requirement and design specifications for Mirada's first interventional radiology application, Simplicit90Y. - Led testing of Mirada’s core diagnostic imaging solutions. - Mentored and coached product analysts and test engineers. - Software as a medical device (SaMD), ISO 13485, ISO 14971, IEC 62304. - Led requirements gathering, use case to system requirement and design specifications for Mirada's first interventional radiology application, Simplicit90Y. - Led testing of Mirada’s core diagnostic imaging solutions. - Mentored and coached product analysts and test engineers. - Software as a medical device (SaMD), ISO 13485, ISO 14971, IEC 62304.



Lloyds Bank

• United Kingdom
• Banking
• 700 & Above Employee

• Software Test Lead

  • Apr 2011 - Sep 2014

  Updated testing processes in the Business Change function, improving software quality by managing, planning and executing multi-level testing. Led a change in testing strategy for the organisation’s £20m Transformation programme. Updated testing processes in the Business Change function, improving software quality by managing, planning and executing multi-level testing. Led a change in testing strategy for the organisation’s £20m Transformation programme.



iSOFT

• United Kingdom
• Software Development
• 500 - 600 Employee

• Software Test Analyst

  • Feb 2009 - Mar 2011

  iSoft built software for healthcare providers worldwide. Successfully managed system testing, coordinating offshore development, testing and support teams – resulting in marked improvements in software quality. Designed, executed and documented testing for numerous legacy and modern healthcare development projects. iSoft built software for healthcare providers worldwide. Successfully managed system testing, coordinating offshore development, testing and support teams – resulting in marked improvements in software quality. Designed, executed and documented testing for numerous legacy and modern healthcare development projects.



South Canterbury District Health Board

• Timaru, New Zealand

• Business Systems Analyst

  • Jun 2007 - Nov 2008

  Carried out requirements analysis with key stakeholders for a NZ$3 million project to replace core clinical and healthcare systems. Managed a project to satisfy national mental health reporting requirements, including design and development of a data warehouse. First organisation to achieve compliance. Carried out requirements analysis with key stakeholders for a NZ$3 million project to replace core clinical and healthcare systems. Managed a project to satisfy national mental health reporting requirements, including design and development of a data warehouse. First organisation to achieve compliance.



Weetabix

• United Kingdom
• Food Production
• 500 - 600 Employee

• Analyst/Programmer

  • Mar 1999 - Aug 2006

  Designed, developed, tested and supported bespoke business web applications. Designed, developed, tested and supported bespoke business web applications.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Molecular Biologist

  • Jun 1998 - Mar 1999

  Plant molecular biology research. Plant molecular biology research.



Unilever

• United Kingdom
• Manufacturing
• 700 & Above Employee

• Molecular Biologist

  • Sep 1990 - Jan 1997

  Carried out research into fruit ripening and plant cell walls. Published in peer-reviewed scientific journals and patents, and presented at international conferences. Carried out research into fruit ripening and plant cell walls. Published in peer-reviewed scientific journals and patents, and presented at international conferences.