Job Title: Senior Manufacturing Engineer
Location: Galway, Ireland
Department: Operations
Type: Full-Time Position
Position Overview
The Senior Manufacturing Engineer plays a critical role in 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.
* Collaboration: Work with R&D and Quality teams to design and improve manufacturing procedures and workflows.
* Process Validation: 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
* Routine Support: Provide routine support to production operations, helping the team meet daily, weekly, and monthly manufacturing targets.
* Troubleshooting: Troubleshoot and resolve product, process, and equipment issues in collaboration with QA and operations teams.
Equipment Management
* Equipment Selection: Select, install, maintain, and monitor manufacturing equipment to ensure optimal performance.
* Problem-Solving: Address equipment problems and adjust process parameters as needed.
Continuous Improvement
* Lean Principles: Apply principles of Lean, Six Sigma, Statistical Process Control (SPC), and Key Performance Indicator (KPI) analysis to drive continuous improvement.
* Cost Reduction: 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: Bachelor’s degree in Engineering or a related field.
* Industry Experience: Minimum of 5 years’ experience in the medical device industry.
* Manufacturing Expertise: Proven expertise in manufacturing process development and equipment management.
Preferred Attributes
* Start-Up Experience: Experience working in a start-up or scale-up medical device environment.
* Familiarity with Urology: Familiarity with urology or similar therapeutic areas is a plus.