Engineer

On behalf of our Medical Devices Manufacturing Client in Limerick, we are currently sourcing a Engineer to join their growing Team.

Purpose of the role :

As a member of the OEM Engineering group, this role will provide engineering support to manufacturing, new product development and new technology development activities within the Limerick site. Specific focus area will be assigned based on business need.

Key Responsibilities:

• Coordinates and performs work within areas of ownership. Measures and manages team performance as required.

• Actively participate in cross functional teams and value stream initiatives to meet company goals.

• Represents customer interactions including customer visits in a professional, constructive and commercially aware manner.

• Ensures that customer expectations are managed and met in all areas of business interaction.

• Works with Customer Services, Sales, value stream teams to facilitate professional and timely delivery of information relating to quotes, orders, deliveries, complaints and other queries as they arise.

• Leads Product development, new process development or process improvement projects achieving the required standard in cost management, quality assurance, health and safety assurance, productivity and sales growth.

• Carries out day to day engineering functions including but not limited to:

o Process characterisation

o DOE

o Validations

o FMEA

o Problem solving

o Statistical analysis

o Tooling management and design

o Equipment purchase, commissioning and installation

• Upgrade of current, and the development of new equipment and processes including tooling, jigs and fixtures.

• Validation and development of manufacturing processes including materials and processing technology.

• Source and manage vendors for the supply of new equipment and processes.

• Generate and maintain quality documentation, work instructions and CAPA’s in accordance with compliance with relevant standards, ISO 13485, F.D.A, G.M.P. for medical devices, and environmental health and safety.

• Ensure full compliance with regulatory requirements.

• Ensure Quality and EHS policies and procedures are adhered to at all times.

Qualifications/Professional skills/knowledge

• Third level relevant Engineering Degree

• 5+ years’ technical experience in a similar environment

• Basic Project management skills

• Genuine Interest in Engineering and medical device development.

• A strong technical aptitude and deep understanding of catheter manufacturing processes would be an advantage.

• Statistical analysis

• Structured Problem Solving techniques

• Understanding of Lean Principles

• Ability to drive projects to completion

• Technical report writing

• Process validations/FMEA's and protocols

• Understanding of Health & Safety - Machine safety, basic Ergonomics, electrical safety, Chemical safety

• Ability to generate and understanding technical drawing (AutoCAD/Inventor)

• Understanding of new product introduction process

If you have the above skills and experience please contact or Tele:

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