Available to hire
I am a results-driven Process and Production Development Engineer with over 20 years of experience leading QA/QC, product development, risk management, and continuous improvement in medical devices and high-tech manufacturing. I have a proven track record in delivering higher yields, lower rejects and waste, and robust quality systems across global teams, with hands-on work in DFMEA/PFMEA, design controls, and MDR/IVDR remediation.
I enjoy translating complex technical challenges into practical, compliant solutions that meet customer, regulatory, and business goals. I thrive in cross-functional environments and am known for my structured problem-solving mindset, strong leadership, and commitment to delivering measurable results on multi-million pound programs.
Skills
Experience Level
Expert
Language
English
Fluent
Work Experience
Medical Device Consultant at Bio composites Implants UK
November 1, 2024 - April 1, 2025Risk management documentation rewrite/update, FMEAs, risk management system rewrite/update, process/product development, CAPA, NC, process capability improvements.
Medical Device Consultant
June 1, 2023 - March 1, 2024Process development due to risk management issues, updates to QMS.
Medical Device Consultant at GCE (Medical Gas Control Equipment)
September 1, 2022 - May 1, 2023Risk management updates to DFMEAs & PFMEAs, updates to risk documents, training risk engineers, updating risk control measures, PMS data analysis, NC/CAPA (MDR remediation).
Medical Device Consultant at CooperSurgical
May 1, 2022 - September 1, 2022Quality Control, Process Development, New Product Introduction, Risk Management, Supplier Development, Validation Master Plan and Work Instructions. Continuous improvement loop established; packaging improvements led to 100% improvements in incoming/outgoing goods.
Medical Device Consultant at Mayborn
September 1, 2021 - March 1, 2022Mother and Baby Care: Technical File, Risk Management, QMS & PMS (MDR Remediation).
Medical Device Consultant at CooperVision
February 1, 2021 - May 1, 2021Product: Contact Lens Risk Management (MDR Remediation).
Regulatory/Remediation Software Validation Consultant at Thermo Fisher
November 1, 2019 - June 1, 2020MDR/IVD remediation; remediation, document updates, design reviews, protocol development, software validation; regulatory (IVD).
MDR Remediation, Software Validation Consultant at LivaNova
June 1, 2019 - September 1, 2019Lung and Heart machine used in open heart surgery and heart transplantation; GUI/Alarm notifications; protocol development and testing/execution; IFU verification (332 pages).
Risk Consultant at Waters Manchester (IVD Medical Devices)
September 1, 2016 - February 1, 2017Risk management (DFMEA/PFMEA); regulatory compliance; documentation updates; technical writing; ISO 9001/13485/14971 maintenance; audits.
Quality / Continuous Improvement Senior Engineer at Alexander Technologies – Active Medical Device
July 1, 2015 - July 1, 2016ISO 13485 project; QMS development; Lean principles; supplier audits; APQP/PPAP; training; quality awareness; leadership.
Quality and Process Improvement Senior Engineer at Argus Powerbend
May 1, 2014 - January 1, 2015QA/QC; lean process improvements; 8D reports; packaging improvements; continuous improvement.
Quality and Continuous Improvement Manager (Contract) at Essentra
November 1, 2013 - April 1, 2014Quality and CI management; supplier development; process improvements.
Lead NPI, Supplier Quality and Continuous Improvement Consultant at Caterpillar
April 1, 2012 - November 1, 2013APQP/PPAP; supplier development; design reviews; DQ/IQ/OQ/PQ; NC/CAPA; cross-functional collaboration; 200+ PPAPs; OEM supplier collaboration and development.
Senior Continuous Improvement, Quality & NPI Engineer at TRW
April 1, 2007 - March 1, 2012Lean Six Sigma projects; yield improvements 99.99%+; cost savings; training; risk management; audits; new product development support.
Technical Manager at Computer North
February 1, 2004 - March 1, 2007Technical support; IT/servers; manufacturing equipment and system maintenance.
Senior Product and Electronics Design Engineer / Operations Manager at Visitech International
January 1, 2002 - January 1, 2004Product development; design for manufacture; reliability; full lifecycle; safety and quality audits; high-end imaging systems.
Quality / Process Leader at Philips
January 1, 1990 - December 31, 2001Quality, continuous improvement; SPC implementation; training; yield improvement; lean concepts; recognition; Queen's Award; multi-million project.
Medical Device Consultant at GCE (Medical Gas Control Equipment)
June 1, 2023 - March 31, 2024Risk management updates to DFMEAs & PFMEAs, updates to risk documents, training risk engineers, PMS data analysis, NCR/CAPA, MDR remediation; addressed historical product/process issues and customer complaints through root cause analysis.
Medical Device Consultant at Mayborn
May 1, 2022 - September 30, 2022Products: Mother and Baby Care; technical file, risk management, QMS & PMS (MDR remediation).
MDR Remediation, Software Validation Consultant at Thermo Fisher
November 1, 2019 - June 30, 2020Remediation, document updates, design reviews, protocol development, software validation; regulatory (IVD).
Graphic User Interface and Alarm Notifications Designer / Validation Consultant at LivaNova
June 1, 2019 - September 30, 2019MDR remediation; GUI/alarms for surgical systems; protocol development and testing; IFU verification (332 pages).
Medical Device Consultant at Quotient
July 1, 2018 - December 31, 2018MDR remediation; software verification/validation; validation protocols and DHR/DHF/documentation updatess for CE and FDA readiness.
Process/ Product Development and Risk Management Consultant at Maquet/Getinge
March 1, 2017 - July 31, 2018Active medical devices (lung & heart machines) and tubing sets; risk assessment including occurrence rate; NC/CAPA; DQ/IQ/OQ/PQ; audit-friendly risk assessment templates; NC/ CAPA.
Risk Consultant at Waters Manchester
September 1, 2016 - February 28, 2017IVD risk management; regulatory compliance to ISO 9001/13485; DFMEA/PFMEA; documentation; audits.
Quality / Continuous Improvement Senior Engineer at Alexander Technologies
July 1, 2015 - July 31, 2016Quality management system development, risk management, hardware/software development, training in ISO 9001, 13485 & ISO 14971; Lean principles.
Quality Assurance / Continuous Improvement Manager at Argus Powerbend
May 1, 2014 - January 31, 2015ISO 14971 DFMEA/PFMEA; process development; lean improvements; APQP measures; supplier development and audits; 200+ PPAP submissions.
Quality, Continuous Improvement (Senior Engineer) & Product & Process Development Manager at Philips
January 1, 1990 - December 31, 2001Quality, continuous improvement; multi-million pound projects; SPC implementation; lean concepts; production and process development across hardware and assembly lines; travel to multiple sites; Queen's Award for Technological Achievements.
Education
Qualifications
BSc Applied Physics & Micro-Electronics
January 11, 2030 - December 30, 2025HNC in Electrical & Electronic Engineering
January 11, 2030 - December 30, 2025Lean Six Sigma Black Belt
January 11, 2030 - December 30, 2025ISO 13485 QMS Remediation / Compliance
January 11, 2030 - December 30, 2025IVDR/MDR Remediation Expertise
January 11, 2030 - December 30, 2025BSc Applied Physics & Micro-Electronics
January 11, 2030 - December 30, 2025HNC in Electrical & Electronic Engineering
January 11, 2030 - December 30, 2025Lean Six Sigma Black Belt
January 11, 2030 - December 30, 2025ISO 14971 (24971) Risk Management Engineer/Consultant
January 11, 2030 - December 30, 2025ISO 13485:2016 QMS Author / Conformance
January 11, 2030 - December 30, 2025Industry Experience
Healthcare, Manufacturing, Life Sciences, Professional Services, Other
Skills
Experience Level
Expert
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