Paul Donnelly
Director QA/RA at THORASYS Thoracic Medical Systems Inc.- Claim this Profile
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Robert Tweedlie
I have known Paul for all of his 9+ years tenure at Optos. Paul is a very dedicated, industrious Clinical Trials professional. He has very good interpersonal skills for dealing with outside entities such as ethics/IRB committees and healthcare professionals but can also relate well to internal groups such as R&D. His technical background covering medical device design control and validation gives him a very informed perspective for the construction of clinical trials to establish the efficacy of a device. Precursor work in determining if the study is significant/non-significant risk comes naturally given his understanding of the safety certification required. Paul is also fully familiar with the international Good Clinical Practice standard ISO14155 and all the acronyms (CIP, IB, CRF's). In summary, I can thoroughly recommend Paul for any role in the process of taking a prototype/cleared device through clinical trial and generating credible/auditable performance data to support publications and regulatory submissions/claims.
Robert Tweedlie
I have known Paul for all of his 9+ years tenure at Optos. Paul is a very dedicated, industrious Clinical Trials professional. He has very good interpersonal skills for dealing with outside entities such as ethics/IRB committees and healthcare professionals but can also relate well to internal groups such as R&D. His technical background covering medical device design control and validation gives him a very informed perspective for the construction of clinical trials to establish the efficacy of a device. Precursor work in determining if the study is significant/non-significant risk comes naturally given his understanding of the safety certification required. Paul is also fully familiar with the international Good Clinical Practice standard ISO14155 and all the acronyms (CIP, IB, CRF's). In summary, I can thoroughly recommend Paul for any role in the process of taking a prototype/cleared device through clinical trial and generating credible/auditable performance data to support publications and regulatory submissions/claims.
Robert Tweedlie
I have known Paul for all of his 9+ years tenure at Optos. Paul is a very dedicated, industrious Clinical Trials professional. He has very good interpersonal skills for dealing with outside entities such as ethics/IRB committees and healthcare professionals but can also relate well to internal groups such as R&D. His technical background covering medical device design control and validation gives him a very informed perspective for the construction of clinical trials to establish the efficacy of a device. Precursor work in determining if the study is significant/non-significant risk comes naturally given his understanding of the safety certification required. Paul is also fully familiar with the international Good Clinical Practice standard ISO14155 and all the acronyms (CIP, IB, CRF's). In summary, I can thoroughly recommend Paul for any role in the process of taking a prototype/cleared device through clinical trial and generating credible/auditable performance data to support publications and regulatory submissions/claims.
Robert Tweedlie
I have known Paul for all of his 9+ years tenure at Optos. Paul is a very dedicated, industrious Clinical Trials professional. He has very good interpersonal skills for dealing with outside entities such as ethics/IRB committees and healthcare professionals but can also relate well to internal groups such as R&D. His technical background covering medical device design control and validation gives him a very informed perspective for the construction of clinical trials to establish the efficacy of a device. Precursor work in determining if the study is significant/non-significant risk comes naturally given his understanding of the safety certification required. Paul is also fully familiar with the international Good Clinical Practice standard ISO14155 and all the acronyms (CIP, IB, CRF's). In summary, I can thoroughly recommend Paul for any role in the process of taking a prototype/cleared device through clinical trial and generating credible/auditable performance data to support publications and regulatory submissions/claims.
Experience
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THORASYS Thoracic Medical Systems Inc.
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Canada
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Medical Device
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1 - 100 Employee
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Director QA/RA
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Oct 2021 - Present
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Kinova
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Canada
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Automation Machinery Manufacturing
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100 - 200 Employee
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QA Manager
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Mar 2021 - Aug 2021
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Jubilant Radiopharma
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United States
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Senior Medical Device Development Manager
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Aug 2015 - Mar 2021
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Quality Engineer, Medical Device Manager
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Nov 2013 - Jul 2015
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EMCISION LIMITED
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United Kingdom
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Research Services
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Director of Engineering & Quality
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Jan 2013 - Nov 2013
Lead product development activities. Collaborate with key suppliers and contract manufacturers to develop and validate manufacturing processes and to verify product performance. Responsible for compliance to QMS. Lead product development activities. Collaborate with key suppliers and contract manufacturers to develop and validate manufacturing processes and to verify product performance. Responsible for compliance to QMS.
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Optos
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United Kingdom
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Medical Device
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400 - 500 Employee
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Clinical Trial Manager
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Oct 2010 - Sep 2012
Project managed all aspects of product Development Clinical Trials from initiation, through to execution and reporting. Acted as conduit of information between development team and Clinician to ensure on target final product. Developed and maintained relationships with KOLs in Ophthalmology and Optometry. Project managed all aspects of product Development Clinical Trials from initiation, through to execution and reporting. Acted as conduit of information between development team and Clinician to ensure on target final product. Developed and maintained relationships with KOLs in Ophthalmology and Optometry.
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Optos
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United Kingdom
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Medical Device
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400 - 500 Employee
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Clinical Research Associate
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Jan 2006 - Feb 2009
Managing the initiation, execution and reporting of clinical studies to complete pre-market, post-market, retrospective and Investigator-led studies. Played key role in product development projects representing customer voice.
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Validation Engineer
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Jan 2003 - Jan 2006
Overall responsibility for verification and validation activities for the company. Developed and introduced the company Design Control process and coached the development team through the transition.Led activities to develop key vendors.
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Boston Scientific
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Quality Engineer
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Jul 1999 - Jul 2002
Led Multi-functional yield & process improvement teams utilising six sigma skills. Provided quality support to multifunctional teams managing production lines Performed internal audits of the company quality system, focusing on process improvement and GMP & ISO 13485 compliance. Led Multi-functional yield & process improvement teams utilising six sigma skills. Provided quality support to multifunctional teams managing production lines Performed internal audits of the company quality system, focusing on process improvement and GMP & ISO 13485 compliance.
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SLB
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United States
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Technology, Information and Internet
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700 & Above Employee
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Quality Engineer
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Aug 1995 - Jul 1999
Initiated continuous improvement groups to resolve quality and process issues. Internal audit manager. Developed vendor improvement program to meet business needs and cost savings. Contributed significantly to company achieving BS EN ISO 9002 certification. Initiated continuous improvement groups to resolve quality and process issues. Internal audit manager. Developed vendor improvement program to meet business needs and cost savings. Contributed significantly to company achieving BS EN ISO 9002 certification.
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Quality Auditor
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Nov 1993 - Aug 1995
Primary contact on Quality issues for largest customer. Identify and resolve problems in manufacturing processes. Primary contact on Quality issues for largest customer. Identify and resolve problems in manufacturing processes.
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Education
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1992 - 1993
University of the West of Scotland
Post Grad Dip, Quality Engineering -
1987 - 1992
University of the West of Scotland
BEng(Hons), Electrical and Electronic Engineering
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