Medical Devices Product Development Manager

1 week ago

Cork, Cork, Ireland beBeeTechnical Full time €90,000 - €120,000
Product Development Lead – Medical Devices">

This role involves leading cross-functional engineering teams through the full product lifecycle, focusing on systems design, regulatory compliance, and technical leadership. Key responsibilities include driving system-level design for new and existing products, translating stakeholder needs into clear, traceable system requirements, leading integration and testing activities across disciplines, providing mentorship and technical direction across engineering functions, maintaining and developing design control documentation, SOPs, and requirements using tools such as DOORS or Modern Requirements, leading change control and configuration management processes, supporting regulatory submissions in partnership with Quality and Regulatory teams, conducting risk assessments including dFMEA and hazard analysis, collaborating closely with Quality, Manufacturing, Marketing, and Regulatory to ensure smooth development and launch, and developing Excel-based tools and workflows to support efficient documentation and project tracking.

">Requirements">
  • A minimum of 5 years experience in product development, preferably in medical devices.
  • A 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.
">Nice to Have">
  • Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, or a related field.
  • Experience in configuration/change control systems.
  • Background working with complex multi-disciplinary systems.
">Why This Role Matters">
  • The opportunity to work on cutting-edge healthcare technologies.
  • Joining a highly skilled and collaborative R&D team.
  • Enjoying a hybrid work model with Fridays from home.
  • Being part of a company making a real impact in healthcare.
  • Excellent opportunity for career progression.
"],

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