Our client a leading Medical Device Manufacturer is looking for an experience 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 introduction of new tooling or repairs to existing tooling.
Work on phases or sub-tasks of projects or entire projects of moderate complexity, with results influencing project completion.
Represent Manufacturing Engineering in larger projects (new product introductions). Ensure successful project handover to production and provide post-launch support and improvements identified.
Run smaller-scale projects such as introduction of individual equipment, new injection mould tools.
Production support – lead problem solving activities and resolution of production issues.
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 processes 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. 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:
Degree or equivalent experience in a Mechanical/Manufacturing Engineering discipline.
Minimum two years 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.
Desirable:
Experience in production / manufacturing.
Worked in a regulated environment, preferably medical devices (ISO13485). Understanding of Good Documentation Practice and Good Manufacturing Practices.
Equipment / process / tooling validation experience
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.