Manufacturing Engineer

Reference Number: JO-2501-546155
Manufacturing Engineer
Rate: £32,000 – 40,000
Job Type: Permanent
Location: Gloucester

Our client, a leading Medical Device Manufacturer, is looking for an experienced Manufacturing Engineer to join their well-established team.

As a Manufacturing Engineer, you will be responsible for implementing new production equipment and processes.

Key responsibilities include:

1. Collaborating with suppliers (primarily injection moulded part suppliers) for the introduction of new tooling or repairs to existing tooling.
2. Working on phases or sub-tasks of projects or entire projects of moderate complexity, with results influencing project completion.
3. Representing Manufacturing Engineering in larger projects (new product introductions). Ensure successful project handover to production and provide post-launch support and improvements identified.
4. Running smaller-scale projects such as the introduction of individual equipment and new injection mould tools.
5. Providing production support – leading problem-solving activities and resolution of production issues.

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.

Additional responsibilities include:

1. Introducing new equipment and changes to existing equipment and processes.
2. Creating User Requirements for equipment.
3. Process Validation: Creating and executing test protocols and reports (IQ, OQ, and PQ) for equipment and processes.
4. Creating SOPs and Work Instructions for manufacturing operations. Training production staff on new processes.
5. Identifying and undertaking continuous improvement opportunities to improve process quality, cost, and safety.
6. Conducting root cause investigation and resolution for on-site assembly or supplied part production issues.
7. Designing assembly fixtures and gauges using Solidworks software.
8. Supporting Non-Conformance / CAPA process.
9. Supporting Project Management in the delivery of projects on time and on cost.
10. Creating and updating risk assessments using the Process FMEA method.
11. Providing the Operations team with decision-making information by calculating production, labour, and material costs as needed.
12. Assisting in the maintenance of on-site equipment when necessary.
13. Initiating, supporting, and leading 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. All employees have a legal duty to take all care needed for the safety of themselves and others who may be affected by their activities and to co-operate with the employer in complying with statutory requirements.

QUALIFICATIONS AND EXPERIENCE:

Essential:

1. Degree or equivalent experience in a Mechanical/Manufacturing Engineering discipline.
2. Minimum two years of experience in an Engineering position.
3. Proven experience in introducing equipment and new processes or making changes to existing processes.
4. Ability to write standard operating procedures and work instructions clearly and concisely.
5. Manufacturing process design, development, and verification.
6. Problem-solving experience and use of tools such as 8D, 5 Whys, Cause and Effect.
7. Interpreting technical specifications and drawings.
8. Self-managing and able to balance multiple projects simultaneously.

Desirable:

1. Experience in production/manufacturing.
2. Experience working in a regulated environment, preferably medical devices (ISO13485). Understanding of Good Documentation Practice and Good Manufacturing Practices.
3. Equipment/process/tooling validation experience.
4. CAD experience for design and drawings of production or inspection fixtures.
5. Design for Manufacture/Assembly experience – understanding the considerations to design parts for injection moulding, machining, and assembly handling.
6. Knowledge of how to apply tolerances and how to assess tolerance stack on parts and equipment.

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