Chief Systems Architect for Medical Devices

1 week ago

Limerick, Limerick, Ireland beBeeSystemsArchitect Full time €80,000 - €124,000
Job Summary

We are seeking an experienced Chief Systems Architect for Medical Devices to join our team in Limerick. This role is central to the design, development, and commercialisation of life-changing healthcare technologies.

You will lead cross-functional engineering teams through the full product lifecycle—from concept to post-market support. The focus is on systems design, regulatory compliance, and technical leadership.

The ideal candidate will have a strong background in systems engineering and experience in medical devices. They will be skilled in writing SOPs, guidance docs, and technical documentation, and have experience in regulatory environments.

Key Responsibilities
  • Drive system-level design for new and existing products
  • Translate stakeholder needs into clear, traceable system requirements
  • Lead integration and testing activities across disciplines
  • Provide mentorship and technical direction across engineering functions
  • Maintain and develop design control documentation, SOPs, and requirements using tools such as DOORS or Modern Requirements
  • Lead change control and configuration management processes (e.g. CCB, CIT)
  • Support regulatory submissions (FDA, ISO 13485, ISO 14971) in partnership with Quality and Regulatory teams
  • Conduct risk assessments including dFMEA and hazard analysis
  • Collaborate closely with Quality, Manufacturing, Marketing, and Regulatory to ensure smooth development and launch
Required Skills and Qualifications
  • 5+ years in product development, ideally in medical devices
  • Strong background in systems engineering
  • Proven track record of leading technical teams through phase-gate processes
  • Skilled in writing SOPs, guidance docs, and technical documentation
  • Experience in regulatory environments (ISO 13485, FDA QSR, ISO 14971)
  • High proficiency in Microsoft Excel (incl. macros) and Microsoft Project
  • Familiarity with tools such as DOORS, SolidWorks, MATLAB, LabVIEW, Minitab
Benefits
  • Work on cutting-edge healthcare technologies
  • Join a highly skilled and collaborative R&D team
  • Enjoy a hybrid work model with Fridays from home
  • Be part of a company making a real impact in healthcare
Others

This is a senior level position that requires a high degree of autonomy and independence. The successful candidate will have excellent communication and leadership skills, and be able to work effectively in a fast-paced environment.

Seniority Level: Mid-Senior level
Employment Type: Full-time
Job Function: Engineering and Information Technology

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