Manufacturing Engineer

Our client, a leading Medical Device Manufacturer, is looking for an experienced Manufacturing Engineer to join their well-established team. As Manufacturing Engineer, you will be responsible for implementing new production equipment and processes, collaborating with suppliers (primarily injection moulded part suppliers) for the introduction of new tooling or repairs to existing tooling.

Responsibilities of the Role:

• This is a site-based role with the expectation of 3 or 4 days on-site minimum to ensure production support and good collaboration with other team members.
• Introduce new equipment and changes to existing equipment and processes.
• Creation of User Requirements for equipment.
• Process Validation.
• Create and execute test protocols and reports (IQ, OQ, and PQ) for equipment and processes.
• Create SOPs and Work Instructions for manufacturing operations.
• Train production staff on new processes.
• Identify and undertake continuous improvement opportunities to improve process quality, cost, and safety.
• Root cause investigation and resolution for on-site assembly or supplied part production issues.
• Assembly fixture and gauge design using Solidworks software.
• Support Non-Conformance / CAPA process.
• Support Project Management in the delivery of projects on time and on cost.
• Creation and update of risk assessments using the Process FMEA method.
• Provide Operations team with decision-making information by calculating production, labour, and material costs as needed.
• Assist in maintenance of on-site equipment when necessary.
• Continuous improvement - To initiate, support, and lead Continuous Improvement projects as required.
• Health & Safety - All employees are to be aware of and understand their health & safety responsibilities as laid out in the Company's Policy and its associated documentation.

Qualifications and Experience:

• Degree or equivalent experience in a Mechanical/Manufacturing Engineering discipline.
• Minimum two years of experience in an Engineering position.
• Proven experience in introducing equipment and new processes or making changes to existing processes.
• Ability to write standard operating procedures and work instructions clearly and concisely.
• Manufacturing process design, development, and verification.
• Problem-solving experience and use of tools such as 8D, 5 why, Cause and Effect.
• Interpreting technical specifications and drawings.
• Self-managing and able to balance having multiple projects at the same time.
• Experience in production/manufacturing.
• Worked in a regulated environment, preferably medical devices (ISO13485).
• Understanding of Good Documentation Practice and Good Manufacturing Practices.
• CAD experience for design and drawings of production or inspection fixtures.
• Design for Manufacture / Assembly experience – understanding the considerations to design parts for injection moulding, machining, and assembly handling.
• Knowledge of how to apply tolerances and how to assess tolerance stack on parts and equipment.