Colleen Monaghan PhD

Product manager of IVD instrumentation

Product manager and RA/QA specialist Establish QMS system for startup project based on ISO 13485 Content creation: User Manual (Instructions for Use) User testing (formative and summative) Define specifications Create traceability matrix Create Validation Master Plan (VMP), V&V Plan (Validation and verification) Collaborate with third party manufacturers and establish ISO-quality V&V testing UDI concept Risk analysis Clinical evaluation (plan, report and PMS plan)

Product Manager Class 2a Medical Devices Emerging applications: business case Led negotiations third party (build-buy-partner strategy) Led transfer of CER/PMS from MDD-MDR Define product roadmap PLM Product launch Close collaboration with every facet of the company including: Engineering, Regulatory, Clinical and product lifecycle management. Risk management CAPA. Training material sales and distributor Train sales and sales partners Conference attendance.

Patents Start ups Grant writing Networking Establishing connections between industry and academia Working together with researchers at the Donders Institute to create a societal impact from scientific discoveries.

Increased sales by >50% in two years with a completely new team. Responsible for the creation of new product, top choice of the segment with key features set tailored to meet the needs of the user. Product Launch (NPD and agile) Technical specifications Marketing Documentation Train and support sales and sales partners Conference attendance: Started the trend of live demonstations at every conference highlighitng the product's USPs

Functional Electrical Stimulation, calf muscles of stroke to improve push-off during gait. Neurophysiological investigation of muscles (motor response / H-reflex) https://scholar.google.nl/citations?user=Jx-uqwcAAAAJ&hl=en Matlab Medical Ethical Committee Experimentation

Multidisciplinary: anatomy/pysiology, physics, maths, engineering FDA and Medical Device Directives, ISO etc. 1 year internship: Medtronic. R&D, regulatory affairs. Final year project: Biomimetic study of RF sputter coated Ti alloy with Ti metal. AFM, SEM, XPS, FTIR.