EIMEA Client Manager - Medical Device QMS Auditor

May 2024 - Current  

British Standard Institution   EIMEA Region (Based in UK)

Medical Device Auditor for ISO 13485 Quality Management Systems and processes against BSI standards and legal requirements, such as the Medical Devices Directive MDD 93/42/EEC. The role covers clients based across Europe, India, Middle East and Africa regions, apart from the UK. To help medical device companies improve on performances, compliancy and safety on their products according to standards.

• Conducting compliant quality management system assessments at client locations in the EIMEA (Europe, India, Middle East & Africa) region and as well remotely.
• Establish and develop an effective partnership with BSI stakeholders, which secures the commerical relationship and encourages opportunities for business development and increased client satisfaction.
• Manage, Plan and Maintain workloads to provide accurate prompt information to support services.
• Certified in:
  • ISO 13485, ISO 9001
  • MDR(EU 2017/745)
  • MDD(93/42/EEC), AIMDD(90/385/EEC)
  • UK MDR 2002

Medical Device Development Engineer

Aug 2020 - May 2024  

Atlas Endoscopy   Leeds, UK

Lead systems developer towards device integration, and management of operator controls on a robotic endoscope platform for a novel robotic arm assisted endoscopic capsule device.
[Atlas Endoscopy, UK, spin-off company from STORM Labs, University of Leeds.]

• Lead the design, development, and testing of advanced endoscope systems, with a focus on colonoscopes.
• Oversee the integration of cutting-edge technologies such as imaging, optics, and robotics to improve colonoscope functionality and performance.
• Directed and executed detailed design reviews and performance design FMEAs, ensuring compliance with MDR standards for regulatory submissions and approvals (MHRA, UK; IRB/FDA, US).
• Led device development and integration of endoscopic robotic systems with NHS hospital systems, fostering seamless compatibility and collaboration with Leeds General Infirmary and St James University Hospital (UK), as well as Vanderbilt University Medical Center (US).
• Oversaw usability and validation tests with partnered clinical staff to evaluate the efficacy of product design requirements, aligning development with user needs and clinical best practices.
• Overall development functionality and effectiveness of designed systems.
• Lead cross-functional reviews to conduct risk assessments, quality management, and validation activities, ensuring that all products meet or exceed regulatory expectations and ensured adherence to rigorous regulatory standards including ISO 13485, IEC 60601, ISO 8600, ISO 14971, ISO 15189, ISO/IEC 17025, and ISO 10218, safeguarding product conformity and quality.
• Led as a systems and software engineer for the inception and development of a ground-up colon simulator training kit, demonstrating prowess in innovative medical training technology development.
• Led the redevelopment and redesign of the MEE (Magnetic End-Effector - Colonoscope controller) to accomodate for market adoption.
• Manufactured key components towards the First in Human Trials (FHT) in the US
• Strategically sourced and selected suppliers, while consulting with third-party contractors, ensuring stringent quality control and efficient mass manufacturing processes.

Research Associate in Medical Device Development

Oct 2019 - Aug 2020  

STORM Labs   University of Leeds, UK

Prior to completion of my PhD, was scouted into a budding spin-off company to drive the development of a robotic endoscope platform and design system integration devices to existing hospital technologies and operations for clinical investigation.

• Engineered and designed an ergonomic hand-held device to control a 6-DOF robotic arm (LBR MED - KUKA Robotic Arm), integrating onboard electronics, demonstrating adeptness in medical device design and development.
• Orchestrated the seamless integration of standard endoscopic ancillary functions into a bespoke hand-held device on a robotic platform, ensuring optimal functionality and clinical compatibility.
• Executed comprehensive risk management plans, assessments, and analyses on project sub-systems, ensuring adherence to regulatory requirements and mitigating potential hazards.
• Oversaw the operational effectiveness of system development and deployment, ensuring alignment with project goals and objectives while maintaining compliance with industry standards.
• Collaborated on pre-clinical assessments of developed systems in animal and/or cadaveric models in partnership with clinical collaborators, enabling real-world validation of system performance and safety.
• Provided expert guidance and support on bespoke soft-manufacturing methods for ongoing research work within STORM Labs, contributing to the advancement of innovative medical device technologies.
• Adhered to regulatory standards such as ISO 13485, ISO 8600, and IEC 6060-1, ensuring that all developmental activities align with international medical device regulations and quality standards.

Research Assistant in Soft Robotic Devices

Oct 2015 - Oct 2016  

Healthcare Mechatronics   University of Leeds, UK

Developing new methods for sensing and actuation in soft robotics while aiding on-going research work for PhD students and research staff within the Surgical Technologies Laboratory (now, Healthcare Mechatronics since 2021).

• Responsible for the deployment, calibration and maintenance of several test and measurement platforms in the laboratory
• Instron Tensile Tester
• Keyance Optical Microscope
• Bespoke Soft Robotic Pneumatic Pumps
• Bespoke Linear Actuation Stages for Sensor Development and Characterisation
• Bespoke Optical/Laser Measurement Platform
• Programmatically designed DAQ software via NI LabVIEW onto test & measurement platforms for data collection, analysis, and output
• Provided scientific and engineering expertise to solve problems and perform statistical analysis of data to support device/development projects
• Responsible for operations, maintenance, and user-training of several manufacturing equipment in the laboratory
• Vacuum-Cast Machine
• Laser Cutter/Engraver
• Centrifugal Mixer
• Liquid Dispenser
• 3D Printers (FDM, SLA, SLS)
• Managed general operations in-line with University's laboratory standards and health & safety requirements
• Assisted in identification, procurement, development of needed laboratory consumables, manufacturing and test equipment

Research Internship

Jul 2015 - Sept 2015  

Healthcare Mechatronics   University of Leeds, UK

An EPSRC funded research internship project to develop soft robotics in the field of medical or surgical under the Surgical Technologies Laboratory (Healthcare Mechatronics, 2021) at the University.

• Developed a electro-pneumatic control platform to actuate and characterise Soft Robotic creations
• Initiated a streamlined soft fabrication process within the research group
• Led the fabrication of several novel soft sensor developed by the research group
• Developed bespoke linear actuation stages to perform under controlled micro-stepping, measurement and DAQ controls via NI LabVIEW
• Co-authored several publications relating to Magnetic based Soft Sensors

Teaching / Laboratory Assistant

Sept 2013 - Sept 2019  

Faculty of Engineering   University of Leeds, UK

Teaching assistant and Laboratory demonstrator, to provide guidance to students and oversee teaching materials during laboratory sessions.
This work was undertaken at the end of my third year of Bachelors degree and has continued up to the end of my PhD.

Peer Mentor / Student Guide

Sept 2013 - Sept 2015   

Faculty of Engineering   University of Leeds, UK

Part time work whilst starting my 3rd Year of BEng. This part-time work was carried out whilst still studying my undergraduate up to the completion of my MSc. The scope of the role carried out were:

• Showcasing student projects and to help and guide parents and prospective students around the department
• Pastoral support to first year students in the school at the University
• Student representative and Pastoral support to my peers within the study course
• Liase with members of staff of teaching aspects and student issues

PhD Soft Robotics in Surgical Technologies

University of Leeds, School of Mechanical Engineering (UK)

2016 - 2020    PhD Awarded

Thesis Title: Development of a Fabrication Technique for Soft Planar Inflatable Composites

• Leeds International Research Scholarship (LIRS)

• ESPRC Research Internship Scholarship

• 'Best Presentation' - University of Leeds - Robotics Conference 2018

• 'Best Poster'- University of Leeds - Post Graduate Researcher's Competition

MSc Mechatronics & Robotics Engineering

University of Leeds, School of Electronics & Electrical Engineering (UK)

2014 - 2015    Pass with Distinction

Dissertation Title: Design and Development of an Intelligent Control for a Prosthetic Knee
Research Abstract for MEIBioEng-15

• Overall Winner - Poster Competition - MEIBioEng15

• 1st Place - Rehabilitation Robotics - MEIBioEng15

BEng Mechatronics & Robotics Engineering

University of Leeds, School of Electronics & Electrical Engineering (UK)

2011 - 2014    First Class Honours

Dissertation Title: Artificial Intelligence Based Control on a Solar Energy System

• 1st Place - 'Design & Manufacture Team Buggy Suspension Design, Build and Control Race' -    National Instruments (NI), UK

• 1st Place - 'Computer in Engineering Analysis Programming Competition' -    National Instruments (NI), UK

• Portable Sensorised Colon Training Kit - Atlas Endoscopy
• Robotic Endoscopy - Atlas Endoscopy
• Emergency department flow optimisation by using artificial intelligence and
  machine learning models to predict admission into hospital (In collaboration with Dr Lim Mun Kiong)
• Design of a mobile ENT Endosocope (In collaboration with CCB Medical, Penang, Malaysia)

• Development of a Fabrication Technique for Soft Planar Inflatable Composites
• Development and Fabrication of a Magnetic Soft Tri-Axis Tactile Sensor
• Adjustable Compliance Soft Sensor via an Elastically Inflatable Fluidic Dome
• Computation Design Tools for Soft Sensors
• Development of a Calvarial Bone Loading Platform (In-collaboration with UCL, London, UK)
• Fabrication of a Dynamic Vascular Prosthesis for Fontan Procedures (In-collaboration with LGI, Leeds, UK)
• Fabrication of a Soft Reactive Bio-incubator for Muscle Cell Growth (In-collaboration with St-James Teaching Hospital, Leeds, UK)

• Development of a Soft Robotic Control Platform
• Towards Self-Tuning Lower Limb Prothesis

• Quality Management System for Medical Device Derectives - PA Consulting, UK
• Certified SOLIDWORKS Associate (CSWA) Graphic
• Certified LabVIEW Associate Developer (CLAD), National Instruments UK & Ireland
• Code-cademy- Web Development (HTML, CSS, Javascript)
• Code-cademy- Python 2 & 3
• ALLSAFE-Food Hygiene Distance Learning course, Advance Food Safety Ltd, UK