Eric Cooper

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.

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.

BEng (Hons) - Mechanical Engineering - Queen's University Belfast (1991 - 1995)

A Levels - Queen's University Belfast (1991 - 1991)