Technical Leader

2 days ago

Dublin, Dublin City, Ireland beBeeEngineering Full time €80,000 - €130,000
Operations and Service Engineer Position

We are seeking an Operations and Service Engineer to join our growing team. This role requires on-site work at our Manufacturing and Field locations as needed.

About the Role

The Operations and Service Engineer will lead hardware manufacturing and servicing activities, including coordination with contract manufacturing suppliers, distribution centers, and field operations. The successful candidate will ensure the successful delivery of product and hardware asset management activities, compliance with standards and regulations, world-class manufacturing performance, cost efficiency, and continuous improvement initiatives.

Main Responsibilities
  • Technical leadership in manufacturing transfer and ramp-up of new and existing products, supporting manufacturing transitions using design for manufacturability principles.
  • Development and implementation of field service capabilities, including installation, servicing, and repair of products onsite at clinical sites and third-party repair centers, in collaboration with the Clinical and Commercial teams.
  • Management of quality processes, including NCMRs, CAPAs, supplier monitoring, audits, risk management, and internal controls, ensuring compliance with ISO 13485 and other relevant standards for medical devices.
  • Contribution to departmental and company goals, with regular updates to stakeholders on project status and alignment with cross-functional objectives.
Requirements

To be successful in this role, you will require:

  • Bachelor's degree in engineering or a related field, with at least 10 years of experience, including 5 years in a technical leadership role within the medical device industry.
  • Experience working within ISO 13485/FDA regulated quality systems, with understanding of risk management methodologies.
  • Proven track record in manufacturing and field service in a regulated environment; experience with medical device catheter products is a plus.
  • Ability to work effectively in a virtual organization, with cross-functional teams, project facilitation, and on-time project completion.
What We Offer

You will have the opportunity to work on cutting-edge imaging systems that benefit patients and improve healthcare, as part of a dynamic, multinational team focused on culture and individual development. Our learning environment will enable you to enhance and expand your skills and interests, while enjoying a flexible working environment and international culture.

We are an equal opportunities employer and welcome applications from all qualified individuals regardless of ethnicity, sex, disability, religion/belief, sexual orientation, or age.

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