Job Title: Senior Manufacturing Engineer
Location: Galway
Reporting to: Manufacturing Engineering Manager / Operations Engineering Manager
Role Summary
The Senior Manufacturing Engineer will lead manufacturing engineering activities to support the efficient, compliant, and scalable production of medical devices. This role focuses on process development and validation, continuous improvement, equipment and tooling implementation, and cross-functional leadership to ensure products are manufactured safely, cost-effectively, and in line with regulatory and quality system requirements.
Key Responsibilities
Manufacturing Process & Technical Leadership
- Own and improve manufacturing processes to meet Safety, Quality, Delivery, and Cost targets.
- Lead process development / industrialisation activities for new and existing products, including transfer from R&D or external suppliers into manufacturing.
- Provide technical leadership on complex manufacturing issues, root cause investigations, and implementation of robust corrective actions.
- Define and execute process capability improvements (Cp/Cpk, yield, scrap reduction, cycle time optimisation).
- Lead/coordinate process validation activities in line with internal QMS and applicable standards (e.g., IQ/OQ/PQ, PPQ where relevant).
- Support risk management activities (e.g., PFMEA, process risk assessments) and ensure mitigation actions are implemented and sustained.
- Ensure manufacturing documentation is accurate, current, and audit-ready: SOPs, work instructions, routing/BOM inputs, control plans, validation protocols/reports.
- Support regulatory and customer audits by providing technical input and evidence for manufacturing controls.
- Specify, select, and commission new equipment and tooling to support production and capacity expansion.
- Manage equipment change control, URS/specifications, FAT/SAT, commissioning, and handover to production.
- Drive automation and digital manufacturing initiatives where appropriate (e.g., vision systems, traceability, poka-yoke solutions).
- Lead Lean / Six Sigma initiatives to eliminate waste and improve throughput, flow, and right-first-time performance.
- Use data-driven approaches to monitor process performance, identify trends, and implement improvements.
- Coach/mentor engineers and technicians; support structured problem-solving across the broader operations team.
- Partner with Quality, Production, R&D, Supply Chain, Maintenance, and suppliers to deliver robust manufacturing solutions.
- Support supplier/outsourced manufacturing readiness where applicable (process reviews, technical troubleshooting, line readiness).
Required Qualifications & Experience
- Degree in Mechanical, Manufacturing, Biomedical, Industrial Engineering (or related discipline).
- typically 5-8+ years in manufacturing engineering within medical devices (or similarly regulated industries such as pharma/biotech).
- Proven experience leading process validations (IQ/OQ/PQ) and working within a controlled QMS environment.
- Strong track record delivering measurable improvements (yield, scrap, OEE, cycle time, cost reduction).
- Experience with structured problem-solving (8D, DMAIC, A3) and root cause tools (5 Whys, Ishikawa, hypothesis testing).
- Strong documentation skills and experience working under change control.
Desirable / Advantageous
- Knowledge of ISO 13485 and/or FDA 21 CFR Part 820 (or equivalent regulatory frameworks).
- Lean Six Sigma certification (Green Belt / Black Belt).
KSGalway
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