Job Title: Manufacturing Engineer
Roles & Responsibilities: To implement appropriate process controls for manufacturing processes for robust and repeatable commercial product manufacturing.To maximise manufacturing process performance through implementation of continuous improvement methodology.To apply a scientific approach to problem solving, combining analytical and experimental skills to maximise overall equipment effectiveness and efficiency.To ensure that all Engineering work and designs are carried out to appropriate GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards.To manage projects using PM principles with effective timeline management and task coordination and execution.To support the development of new processes in conjunction with Process/Manufacturing/Automation Engineering ensuring that new processes are stable and capable.To provide technical support to new product/technology introductions and ensure change is effectively managed.To ensure that non-conforming products and processes are evaluated and corrected on assigned projects in accordance with process controls and procedures.To successfully complete validations and process improvements using statistical tools and six sigma techniques.To support the development of in-house Subject Matter Experts (SME) across the range of core technologies.To support process/equipment/H&S risk assessment and analysis of risk to product or user.Qualifications and Job Requirements: Honours Degree in Mechanical/Manufacturing Engineering or equivalent discipline with relevant experience.Catheter manufacturing experience is desired.A minimum of 3 years of professional experience in a responsible Manufacturing Engineering/Process Development role within the Medical Device/Healthcare.Proven and successful implementation of continuous improvement initiatives is essential.A complete understanding of how to measure production line performance is required.
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