Experience

Corryn Biotechnologies

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

• Co-Founder, Director

  • Mar 2023 - Present



Nanofiber Solutions

• United States
• Biotechnology Research
• 1 - 100 Employee

• Program Manager

  • Aug 2019 - Jan 2023

  • Manage multiple concurrent projects with international teams to develop and manufacture Class IIb medical and combination devices under an ISO 13485 and MDR compliant quality system • Initiated, implemented, and continue to support company framework to standardize project management practices and capture knowledge for use in current and future product development endeavors • Provide technology and operational support for subsidiary businesses • Plan, communicate, and control product… Show more • Manage multiple concurrent projects with international teams to develop and manufacture Class IIb medical and combination devices under an ISO 13485 and MDR compliant quality system • Initiated, implemented, and continue to support company framework to standardize project management practices and capture knowledge for use in current and future product development endeavors • Provide technology and operational support for subsidiary businesses • Plan, communicate, and control product development budgets totaling over $2M across all projects • Lead efforts to create and optimize a novel manufacturing process to produce a combination medical device meeting user requirements and regulatory guidelines • Research and interpret regulatory documents, past regulatory decisions, and recognized standards (ISO, ASTM, etc.) to better define regulatory pathways and user needs • Coordinate with external partners to develop, procure, and analyze detailed studies to complete design verification and validation efforts • Write, review, and approve Quality Management System documents to ensure product development procedures meet ISO and FDA regulatory standards • Prepare FDA pre-submissions to clarify regulatory pathway towards device clearance or approval

• Head of Product at IkoStrips Inc

  • Oct 2020 - Oct 2022

  Business Operations and Technical lead developing innovative orally dissolvable drug delivery products. • Product strategy creation • Lead business operations • Created house-brand of strips for direct-to-consumer sales • Scaled up manufacturing activities from prototype to 1 million units/month • Coordinate work at external suppliers



Xeltis

• Netherlands
• Medical Device
• 1 - 100 Employee

• Technical Lead Pulmonary Valve

  • Nov 2017 - Mar 2019

  Eindhoven Area, Netherlands Technical Project lead developing world-first restorative pulmonary valve devices for congenital heart defects in pediatric patients. • Key contributor for overall program strategy • Led concept creation of future product generations • Technical oversight of Senior and Junior engineers • Translate clinical and pre-clinical inputs into design improvements • Project risk management • Coordinate monthly engineering prioritization

• Principal R&D Engineer

  • Jul 2016 - Mar 2019

  Eindhoven Area, Netherlands Process technical lead developing innovative manufacturing processes for cardiovascular medical devices. • Led the manufacturing process of the world first restorative pulmonary valve clinical trial • Developed and refined manufacturing processes • Plan and execute process/test method validations • Lead process FMEA according to ISO 13485 and other relevant standards • Coordinate suppliers to develop state of the art manufacturing and quality control equipment

• Production and Process Development Manager

  • Feb 2015 - Jun 2016

  Eindhoven Area, Netherlands Team manager responsible for the transition from R&D to a small-scale quality-controlled cleanroom manufacturing facility. • Hired and led two small multidisciplinary teams • Multiplied by 4 the manufacturing capacity and reduced scrap rate from 40% to 3% by co-developing and implementing measurement tools and new processes • Key asset in the implementation of Quality Management System and successful certification of ISO 13485

• Electrospinning Expert

  • Feb 2014 - Jan 2015

  Eindhoven Area, Netherlands Electrospinning technical lead developing the technology into a medical device capable manufacturing process. • Developed innovative manufacturing approaches to overcome product (pulmonary valve requirements) development challenges • Led collaborations with external industrial partners • Mentored and trained employees on applying the technology to innovative applications



Università di Trento

• Italy
• Research Services
• 700 & Above Employee

• Marie Curie Postdoctoral Fellow

  • May 2011 - Jan 2014

• Postdoctoral Fellow

  • May 2010 - Apr 2011

• Ph.D. Student

  • Nov 2006 - Apr 2010



QUT (Queensland University of Technology)

• Australia
• Higher Education
• 700 & Above Employee

• Visiting Marie Curie Postdoctoral Fellow

  • Jul 2011 - Jun 2013

  Brisbane, Australia



Colorado State University

• United States
• Higher Education
• 700 & Above Employee

• Visiting Postdoctoral Fellow

  • May 2010 - Nov 2010