Innovative System Engineering Leadership

6 days ago

Limerick, Limerick, Ireland beBeeInnovator Full time €96,000 - €126,000
\System Engineering Lead\

This is a senior engineering position for a R&D Tech Lead, leading cross-functional teams through the full product lifecycle from concept to post-market support.

\Job Description\
  • \
  • 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\
  • Develop Excel-based tools and workflows to support efficient documentation and project tracking\\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\
    • Strong communication and leadership skills\\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\
      • Excellent opportunity for career progression\\Why Apply?\

A great opportunity to develop your career as a System Engineering Lead and contribute to life-changing healthcare technologies.

\

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