Position:
Manufacturing Engineer
Department:
Engineering
Reporting to:
Group Engineering Lead
Contract type:
Full time Permanent
Summary:
Working within the core Engineering group, as an ME you will play a crucial role in the successful manufacture of our medical devices. You will leverage your technical expertise, problem-solving abilities, and validation experience to ensure the efficiency and quality of our manufacturing processes.
Key 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.
Qualification Requirements:
· Honors Degree Level 8 in Engineering or equivalent discipline.
· A minimum of 3-5 years of professional experience in a responsible Manufacturing Engineering role within the Medical Device/Healthcare.
Knowledge, Skills and Abilities:
·
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.
Other:
* Responsible for providing regular progress updates to senior management and leading or participating in routine manufacturing meetings to support operational goals.
* Maintain metrics and report weekly on each metric.