Colleen Monaghan PhD
Until 2020, Product Manager, Hocoma AG
Kusterdingen, Germany
Timeline
Professional experience for Colleen Monaghan PhD
Current , since Sep 2020
Product Manager
Swiss Prosthetics
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)
2 years and 9 months, Jan 2018 - Sep 2020
Product Manager
Hocoma AG
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.
1 year and 1 month, Jun 2015 - Jun 2016
Knowledge Transfer Specialist
Donders Institute, Radboud University, the Netherlands
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.
5 years and 4 months, Feb 2010 - May 2015
Product Manager
Xsens
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
Educational background for Colleen Monaghan PhD
8 years and 2 months, Sep 2001 - Oct 2009
Biomedical engineering
University of Twente
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
3 years and 10 months, Sep 1997 - Jun 2001
Biomedical engineering
University of Ulster, Jordanstown
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.
Languages
English
First language
Dutch
Fluent
German
Intermediate