Manufacturing Engineer – (Cork)
A medical device manufacturer based in Cork is seeking a highly motivated Manufacturing Engineer to support the development, optimization, and continuous improvement of manufacturing processes within a regulated, high‑precision environment. The successful candidate will play a key role in driving operational excellence, ensuring compliance, and supporting the introduction of new products and technologies.
Key Responsibilities
Develop, optimize, and validate manufacturing processes to ensure safety, quality, and efficiency.
Lead and support continuous improvement initiatives using Lean, Six Sigma, and data‑driven methodologies.
Collaborate with cross‑functional teams—R&D, Quality, Operations, and Supply Chain—to support product launches and process transfers.
Generate and maintain process documentation, including work instructions, validation protocols (IQ/OQ/PQ), PFMEAs, and control plans.
Troubleshoot and resolve engineering and production issues to minimize downtime and maintain product quality.
Support equipment installation, qualification, calibration, and lifecycle management.
Lead root cause analysis and implement corrective and preventive actions (CAPA) in compliance with regulatory requirements.
Partner with suppliers and vendors to support equipment upgrades, tooling development, and process improvements.
Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and all relevant medical device regulations.
Provide technical support and training to production teams.
Required Skills & Experience
Bachelor’s degree in Mechanical, Manufacturing, Biomedical, or related engineering discipline.
3+ years of experience in a medical device, pharmaceutical, or highly regulated manufacturing environment.
Strong knowledge of Lean Manufacturing and/or Six Sigma methodologies.
Experience with process validation (IQ/OQ/PQ) and regulatory compliance.
Proficiency in technical documentation, troubleshooting, and problem‑solving tools.
Strong understanding of manufacturing technologies such as CNC machining, plastics processing, automation, or assembly systems.
Excellent analytical, organizational, and communication skills.
Ability to work effectively in a fast‑paced, collaborative, and highly regulated environment.
Desirable Qualifications
Six Sigma Green Belt or Black Belt certification.
Experience with cleanroom operations.
Familiarity with statistical analysis tools (e.g., Minitab).
Experience with design for manufacturability (DFM) and automation integration.
Background in project management or NPI (New Product Introduction).
Location and Salary: Cork, County Cork, Ireland €42,000.00-€50,000.00
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Manufacturing and Project Management
Medical Equipment Manufacturing
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