Eric Cooper
Principal Device Engineer specialising in medical devices and combination products
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About
Principal Device Engineer specialising in medical devices and combination products, with 25+ years' experience delivering compliant, manufacturable, and drug‑delivery systems. Expert in design controls, verification & validation, risk management (ISO 14971), DHF development, and global regulatory compliance (ISO 13485, FDA 21 CFR 820).
Six Sigma Black
Belt with a strong record of resolving complex device issues.
Experience
Principal Device Engineer – Combination Products - TEVA NI LTD. - Larne
(2023-04)
Technical lead for intravitreal and intrauterine drug‑delivery systems.
- Ownership of design controls, DHF development, and regulatory compliance.
- Led risk management activities (ISO 14971), including hazard analysis, FMEA, and risk‑benefit evaluation.
- FEA for cyclic fatigue of medical device components
- Attended and contributed to FDA pre-ANDA meetings for combination products.
- Provided technical leadership across global teams and mentored junior engineers.
- Supported CAPA investigations, supplier qualification, tooling reviews, and manufacturing readiness.
Senior Device Engineer – Combination Products - TEVA NI LTD. - Larne
(2018-07 - 2023-04)
Technical lead for oral and rectal drug‑delivery systems.
- Delivered full verification & validation programmes including protocol creation, fixture design, method development, execution oversight, and reporting.
- Provided engineering leadership for supplier qualification, tooling reviews, and manufacturing readiness.
- Collaborated with global teams on root‑cause investigations, CAPA activities, and continuous improvement.
- Supported sustaining engineering across multiple generic device platforms.
Senior Sustaining Engineer & Six Sigma Black Belt – Flow Control Products - SCHLUMBERGER - Belfast & Houston
(2014-01 - 2018-07)
- Designed and sustained precision mechanical systems for downhole applications.
- Led qualification testing programmes aligned with regulated engineering standards.
- Delivered continuous improvement projects using Lean/Six Sigma methodologies.
- Mentored junior engineers and supported technical recruitment.
Team Leader – Intelligent Flow Control Improvement Project - SCHLUMBERGER - Belfast & Houston
(2013-04 - 2013-12)
- Led global product improvement initiatives using structured Six Sigma methodologies.
- Developed and approved qualification test plans; executed testing for upgraded designs.
Sustaining Engineer – Flow Control Products - SCHLUMBERGER - Belfast & Houston
(2009-11 - 2013-03)
Delivered sustaining engineering for complex mechanical assemblies.
Engineering Team Leader – Core Completions - SCHLUMBERGER - Belfast & Houston
(2008-12 - 2009-10)
Led engineering team for safety‑critical completion products.
- Set team objectives and conducted performance appraisals.
Senior Quote Support Engineer - SCHLUMBERGER - Belfast & Houston
(2006-02 - 2008-11)
- Reviewed technical specifications and tender documents.
- Compiled technical quotations and provided global technical support.
Design Engineer – Gauge Mandrels & Safety Valves - SCHLUMBERGER - Belfast & Houston
(1997-02 - 2006-01)
Designed and sustained safety‑critical mechanical devices, specialising in gauge mandrels.
- Led transfer of mandrel design support from France to Belfast.
- Used Creo (Pro‑E) and Creo Simulate (Mechanica) for 3D modelling and FEA.
Design Engineer - F.G. WILSON / CATERPILLAR - Larne
(1995-08 - 1997-02)
Designed diesel generator systems including exhaust, vibration, and acoustic performance.
Technical Support Engineer (Intern) - INGERSOL DRESSER POMPES - Le Mans, France
(1993-08 - 1994-07)
Provided technical support for centrifugal pumps across Europe.
- Liaised with customers in French and English.
Education
BEng (Hons) - Mechanical Engineering - Queen's University Belfast (1991 - 1995)
A Levels - Queen's University Belfast (1991 - 1991)
