The Senior Process Engineer will be responsible for managing project workstream deliverables and process engineering requirements through technology transfer and commercialization in a new manufacturing facility.
- Ensure transferred processes are designed for manufacture, automated, innovative, cost effective and meet all Quality and EHS regulatory requirements
- Support production equipment transfer into Cork, takes a hands on lead role in activities required to achieve Commercialization
- Coordinate and supervise a project workstream team as required to achieve project/site goals and key metrics.
- Support recruitment, onboarding and development of talented and competent team of process/project engineers. Coach and mentor the group and support continuous learning and development toward a performance excellence goal.
- Project Manage / Co-ordinate key projects/project workstreams within the areas of assigned responsibility.
- Support the Continuous Improvement strategy in conjunction with the Manufacturing, Quality and Maintenance Engineering functions in the area. Identify, support, or direct the execution of improvement efforts to reduce waste, increase yields and improve product quality in the Assembly manufacturing area.
- Manage / support process, product and quality issues to achieve long term solutions. This includes technical support and contact with external site stackholders and customers on process and product lines.
- Identify and develop risk-based approach to change management in conjunction with validation and QA groups.
- Support the more junior engineers in the development and execution of effective process validation protocols.
- Support all engineering tasks in the areas of BOMs, routings, line layouts, time studies, value stream mapping etc.
- Ensure that accurate and representative process data is generated, gathered, analysed and trended
- Deliver regular reporting of process performance and provide technical process support to sustained manufacturing operations.
- Apply and lead DMAIC – Six Sigma approaches to solve issues and reduce variation in all Assembly II manufacturing areas.
- Participate in Customer Complaint investigations as required.
- Maintain and develop process documentation and procedures.
- Support EHS to identify and resolve health and saftety related issues.
Note: This role involves travel abroad, in some cases for extended periods.
- Engineering Degree or relevant Third Level Qualification.
- Minimum 5-8 years experience in medical device or similar industry with an established track record (Strong candidates coming from an automotive/ semiconductor / electronics or other GMP / FDA regulated background will also be considered)
- Experience in developing and executing effective process validations is essential in this role. (MVP’s, OQ, PQ’s etc)
- Working knowledge of validation systems.
- Moulding or Overmoulding experience a distinct advantage.
- Strong leadership skills including development of engineering staff, successfully executing engineering objectives and projects, ability to lead in a cross-matrix work environment.
- Excellent use of initiative and adaptable to changing priorities
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service-oriented attitude.
- Effective presentation and communication skills- both written and verbal
- Analytical & problem-solving skills using recognised methodologies, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment.
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