Arthur P.

Experience

• 

  Brainlab

  Jan 2006 - Jan 2007

  Project Engineer, Radiation Oncology

  100% domestic and international travel (USA, Canada and EU)

• 

  GSK

  Jan 2007 - Jan 2010

  Senior R&D Product Development Engineer, Biomaterials

  NovaMin Technology acquired by GSK

• 

  CIVCO Medical Solutions

  Jan 2010 - Jan 2013

  R&D Engineering Manager, Ultrasound

  PCI Medical acquired by CIVCO Medical.R&D Engineering Manager with additional Quality Assurance and Regulatory Affairs responsibilities.

• 

  Medtronic

  Jan 2013 - Jan 2017

  Senior R&D Program Manager, Surgical Powered Stapling / Minimally Invasive Surgery

  Covidien acquired by Medtronic.

• 

  Philips Capsule

  Jan 2017 - Jan 2019

  Director, Regulatory Affairs & Quality Assurance, SaMD / Clinical Surveillance

  Bernoulli Health acquired by Capsule / Philips.Member of the site Executive Leadership Team (ELT) for QA and RA functions.

• 

  KUBTEC Medical Imaging

  Jan 2019 - Jan 2020

  Director, R&D Engineering, Capital Equipment / Medical Imaging
• 

  Flatiron Health

  Jan 2020 - Jan 2022

  Senior Manager, Integrated Quality, AI/ML - Real World Patient Data & Evidence / Oncology
• 

  Welldoc

  Jan 2022 - now

  Director / Global Head, Quality Assurance, SaMD / Diabetes Management

  1) Direct report to CEO2) Global department head (USA & India) 3) Management representative for ISO 13485, EU MDR & MDSAP (USA, Canada, Australia, Japan) certified QMS4) Restructured, reorganized, hired and onboarded global QA team5) Direct management of global QA team across the USA and Bangalore, India 6) QA lead on several successful new product development Class II SaMD launches7) Provide cross-functional support in focus areas such as: Usability / Human Factors Engineering, Risk Management, Regulatory Affairs, Design Control, Agile / Scrum Methodologies, HITRUST, Clinical Study Monitoring, EU MDR, Software Tool Validation / Computer System Validation Show less