Product and Process Engineer

We are hiring a strong Product & Process Engineer to lead product industrialisation and process engineering within a medical device manufacturing environment. This role is responsible for transferring products from development into compliant, stable production and for driving measurable improvements in safety, quality, yield, cost and throughput—while operating fully within an ISO 13485/FDA-regulated Quality Management System.

Key responsibilities

• Lead manufacturing process development for new and existing medical device products from design transfer through to validated, routine production.
• Partner with R&D to ensure DFM/DFA, manufacturability, testability, and robust process windows prior to transfer.
• Own technical deliverables for Design Transfer including process flows, routings, BOM alignment, equipment/fixture requirements, and training plans.

• Plan and execute process validation activities (IQ/OQ/PQ, PPQ where applicable), including protocols, sampling rationale, acceptance criteria, and final reports.
• Develop/maintain key quality documentation: PFMEA, Control Plans, SOPs/Work Instructions, process flow diagrams, validation master plans (as applicable).
• Ensure changes are managed through formal change control (ECR/ECO) and support risk management activities aligned to ISO 14971.

• Drive improvement projects using Lean/Six Sigma tools to reduce scrap, rework, deviations and customer complaints while improving capability and throughput.
• Lead structured problem-solving investigations and CAPA support: 8D/A3, 5 Whys, Fishbone, containment, corrective and preventive actions.
• Implement and monitor SPC/process capability (Cp/Cpk), define control limits, and establish ongoing process monitoring where needed.

• Specify, develop and commission manufacturing equipment, tooling, fixtures and test systems; support FAT/SAT and equipment qualification where required.
• Work with suppliers/contract manufacturers to ensure processes are capable, compliant, and appropriately validated.

• Collaborate with Quality, Production, Supply Chain and Regulatory to support audits, deviation investigations, nonconformance disposition, and complaint trending.
• Provide hands-on floor support: troubleshooting, line balancing, training, and standard work deployment.

Required qualifications & experience

• Degree in Mechanical, Biomedical, Manufacturing, Industrial, Chemical, Materials Engineering (or similar).
• Typically 5–8+ years in process/product/industrial/manufacturing engineering within a regulated manufacturing setting; medical devices strongly preferred.
• Demonstrated experience bringing processes to a validated state and sustaining them in production.
• Strong understanding of working within a QMS and managing documentation rigorously.

• Hands-on experience with IQ/OQ/PQ and writing/ executing validation protocols and reports.
• Strong process documentation capability: PFMEA, Control Plan, SOPs/WIs, process flow mapping.
• Root cause/problem solving: CAPA support, 8D/A3, 5 Whys, data-led troubleshooting.
• Statistical and data skills: SPC, Cp/Cpk, basic capability analysis; DOE an advantage.
• Knowledge of manufacturing processes relevant to med devices (depending on site): assembly, adhesive bonding, welding, moulding, machining, packaging, EO/gamma (if applicable), test/inspection systems, cleanroom operations.

• ISO 13485, 21 CFR Part 820 (FDA QSR), GMP Principles.
• Risk management alignment to ISO 14971.
• Understanding of process validation guidance and documentation expectations in audited environments.

KSGalway

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Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd. Gi Group Ireland Limited are acting as an Employment Agency in relation to this role.

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