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Equipment Systems Engineer

2 weeks ago

Galway, Galway, Ireland beBeeMedicalDevice Full time €60,000 - €80,000
Job Overview

We are seeking an experienced CSV Specialist to join our team in Galway, working on a contract basis with a leading medical device client.

Note: No sponsorship will be provided for this contract role. A validation Stamp 1G or Stamp 4 is required at minimum. Previous Medical Device experience is essential.

Responsibilities
  • Develop and maintain lifecycle documentation, including Functional Specifications, software design specifications, calibration specifications, and other associated documentation required for equipment and systems.
  • Create and execute validation documentation such as IQ/OQ/PQ, Test Method Validations.
  • Design and implement test methods, develop or modify Test Method Validation protocols and reports.
  • Develop or modify validation packages, design plans, and risk management deliverables (e.g. FMEAs).
  • E nsure software is controlled and stored as per validation procedure guidelines.
  • Maintain quality standards by promptly reporting noncompliance issues to management.
  • Collaborate with the Quality department to ensure all validations align with validation standards.
  • Work with key stakeholders on project deliverables.
  • Deliver project outcomes and monitor project schedules and scope changes to ensure team deadlines are met.
Required Skills and Qualifications
  • Bachelor's degree in Life Science, Engineering, or closely related discipline is required.
  • Previous Research & Development experience within the medical device industry is advantageous.
  • 3-4 years of Equipment and CSV experience within the medical device industry.
  • Excellent communication, team, and organisational skills are required.
  • Able to use initiative and be proactive in task management to set and meet deadlines.
  • Able to work co-operatively and effectively with others to establish good working relationships.
Benefits
  • This mid-senior level position offers a great opportunity to grow your career in the medical device industry.
  • You will have the chance to work with a dynamic team and contribute to various projects.
Others
  • The employment type for this role is Contract.
  • The job function falls under Engineering, Production, and Manufacturing.
  • The industries include Medical Equipment Manufacturing and Manufacturing.