Senior Technical Manufacturing Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeOperations Full time €100,000 - €120,000
Job Overview

The Operations & Service Engineer will lead hardware manufacturing and servicing activities, including coordination with contract manufacturers, distribution centers, and field operations. This role requires on-site work at our Manufacturing and Field locations as needed.

Main Responsibilities:
  • Technical Leadership: Provide guidance in manufacturing transfer and ramp-up of new and existing products, utilizing design for manufacturability principles.
  • Field Service Development: Establish and implement field service capabilities, including installation, servicing, and repair of LUMA Vision products onsite at clinical sites and third-party repair centers.
  • Quality Process Management: Oversee 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.
  • Departmental Alignment: Contribute to departmental and company goals, providing regular updates to stakeholders on project status and alignment with cross-functional objectives.
Required Skills and Qualifications:
  • A 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 an understanding of risk management methodologies.
  • A proven track record in manufacturing and field service in a regulated environment; experience with medical device catheter products is a plus.

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