Job Title: Senior Lead Systems Engineer
About the Role:
We are seeking a highly skilled and experienced Senior Lead Systems Engineer to join our team in Galway. As a key member of our engineering department, you will be responsible for planning, implementing, and maintaining a comprehensive Factory Systems Infrastructure in line with corporate guidelines and specific customer requirements.
Responsibilities:
* Proactively manage and support the existing Automation infrastructure for optimal performance and minimized downtime
* Collaborate with the IT Group, Application Group, External Technical Resources to provide comprehensive support of all Automation and Information Systems and Technologies
* Provide final third-level support on all technical issues
* Provide solutions that implement industry best practice to deliver improved productivity and efficiency throughout the organization
* Install and deploy systems, software, and peripherals as required, liaising with external vendors and service contractors as appropriate
* Source appropriate equipment and services through appropriate liaison with the Purchasing department
* Provide Technical Direction for all new infrastructure developments
* Develop, implement, and manage comprehensive contingency plans for all critical systems including regular documented tests
* Utilize a Project Management methodology to plan, coordinate, and implement Key projects assigned by Business Unit Managers
* Provide regular reports to Management and delivers project within agreed time-frames and budgets
* Ensure documentation and procedures are written and controlled to ISO13485 standards
* Utilize Continuous Process Improvement methodologies with a strong basis in statistical analysis to improve the overall quality of all manufacturing systems
* Provide innovative inputs to new and existing production lines in the areas of control, data collection, motive power, robotics, vision systems, and communications
* Knowledge of SQL Server settings and database settings and the impact on performance
* Database Administration in general for SQL Server. Working closely with the Database Admin team to ensure smooth deployments of application updates
Requirements:
* Excellent Project Management and Time Management skills
* Excellent communication Skills both written and verbal
* Experience creating CAPA, FMEA, SOPs, Control Plans, and performing validation (FAT, SAT, IQ, OQ, PQ)
* Software development and validation
* Ability to effectively communicate manufacturing plans, proposals, results, and negotiate options at management levels
* Strong analytical and problem-solving skills
* Excellent interpersonal & communication skills. Strong report writing & data analytical capabilities
* Advantageous to have knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485, specifically in the areas of Change Control and Validation
Benefits:
We offer a competitive total reward package including Performance related bonus program, company pension, and health insurance. We also provide opportunities for training and development, and a collaborative culture with strong leadership imperatives to foster your growth and professional opportunities.
About Us:
We are a global company enabling the world's best brands. Through our recognized customer-centric approach, we partner with leading companies in various industries to deliver solutions for their most complex challenges. We bring global expertise and insight at every stage of product development from drawing board to full-scale production and after-market services.
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