Overview
Working within the core Engineering group, as an ME you will play a crucial role in the successful manufacture of medical devices.
You will leverage your technical expertise, problem-solving abilities, and validation experience to ensure the efficiency and quality of the manufacturing processes.
Responsibilities
To execute tasks as assigned within projects and lead assigned work tasks to successful outcomes.
To implement appropriate process controls for manufacturing processes for robust and repeatable commercial manufacturing.
To maximize manufacturing process performance through implementation of continuous improvement methodology.
To apply a scientific approach to problem solving, combining analytical and experimental skills to maximize 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 support the development of new processes in conjunction with Automation Engineering ensuring that new processes are stable and capable.
To provide technical support to new product/technology introductions and ensure changes are effectively managed.
To ensure that non-conforming products and processes are evaluated and corrected on assigned responsibilities 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
Honors Degree Level 8 in Engineering or equivalent discipline.
A minimum of 3-5 years of professional experience in a Manufacturing Engineering role within the Medical Device/Healthcare sector.
Balloon forming experience required.
Ability to identify optimal forming parameters for yield and functional performance.
Proven and successful implementation of continuous improvement initiatives is essential.
Proficiency in CAD software.
Strong report writing and documentation skills, with high attention to detail.
Strong knowledge of regulatory requirements and quality standards.
Knowledge of validation and qualification (IQ, OQ, PQ) for equipment and processes.
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