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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