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Senior Manufacturing Engineer
4 weeks ago
Senior Manufacturing Engineer
Location: Galway
Department: Operations
Type: Full-Time
Position Overview
The Senior Manufacturing Engineer is responsible for supporting and optimizing the manufacture of medical device products. This includes leading process improvements, managing equipment and materials, providing production line support, and ensuring operational efficiency in compliance with quality and regulatory standards.
Key Responsibilities
Manufacturing & Process Engineering
- Lead manufacturing projects to develop, optimize, and validate production processes.
- Collaborate with R&D and Quality teams to design and improve manufacturing procedures and workflows.
- Execute process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), in line with the Quality Management System (QMS).
Operations Support
- Provide routine support to production operations, helping the team meet daily, weekly, and monthly manufacturing targets.
- Troubleshoot and resolve product, process, and equipment issues in collaboration with QA and operations teams.
Equipment Management
- Select, install, maintain, and monitor manufacturing equipment to ensure optimal performance.
- Address equipment problems and adjust process parameters as needed.
Continuous Improvement
- Apply principles of Lean, Six Sigma, Statistical Process Control (SPC), and Key Performance Indicator (KPI) analysis to drive continuous improvement.
- Identify and implement cost-effective solutions to reduce cost of goods sold (COGs) as part of commercial readiness and scale-up plans.
Required Skills & Experience
- Bachelor's degree (Level 8) in Engineering or a related field.
- Minimum of 5 years' experience in the medical device industry.
- Proven expertise in manufacturing process development and equipment management.
- Solid understanding of quality management systems (QMS), process controls, and regulatory compliance.
- Strong problem-solving and analytical skills.
- Excellent communication skills with the ability to liaise effectively with internal and external stakeholders.
- Self-motivated, with a demonstrated ability to work both independently and within cross-functional teams.
- Strong organizational, presentation, and project management abilities.
Preferred Attributes
- Experience working in a start-up or scale-up medical device environment.
- Familiarity with urology or similar therapeutic areas is a plus.
