Medical Device Systems Engineer

6 days ago

Limerick, Limerick, Ireland beBeeLeadership Full time €120,000 - €160,000
Key Engineering Leadership Role

A distinguished engineering professional is required to spearhead cross-functional teams in the development of life-changing healthcare technologies.

This critical role will play a pivotal part in the success of our medical device projects, necessitating a strong background in systems engineering, regulatory compliance, and technical leadership.

Duties:
  • 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
  • Support regulatory submissions 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
Requirements:
  • 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)
  • High proficiency in Microsoft Excel (incl. macros) and Microsoft Project
  • Familiarity with tools such as DOORS, SolidWorks, MATLAB, LabVIEW, Minitab

Key Skills: Strong problem-solving skills, effective communication, strategic thinking, and collaborative mindset.

Education: Bachelor's degree in Engineering or related field.

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