Manufacturing Engineer I/II
Provides daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety).
Develop and implement manufacturing business improvement projects and processes for disposable medical devices. Support teams to make improvements to existing devices and manufacturing processes. Lead less complex projects independently with minimal supervision.
Analyses process, product, material or equipment specifications and performance requirements.
Under broad supervision / guidance compiles and analyses operational, test and experimental data to establish performance standards for newly implemented or modified products / processes.
Summarises, analyses and draws conclusions from test results leading to effective technical resolution.
Troubleshoots new products / process working closely with product development.
Continually seeks to drive / improvements in process design, layout and operational performance.
Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
Actively promotes and participates in a cross -functional teamwork environment.
Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
Gives technical guidance to Associate Engineers and technicians.
Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
Demonstrate a primary commitment to patient safety and product quality.
Understands and comply with all the regulations governing the quality systems.
Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
Qualifications and Experience:
NFQ Level 8 in a Technical Discipline (Science, Biomedical, Mechanical, Manufacturing, etc.)
Minimum 3-5 years’ experience working at an Engineering level, ideally in Medical Device industry or other highly regulated environment
Project Management experience highly desirable