R&D Lead in Medical Device Development

2 days ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €90,000 - €135,000
Job Opportunity: Principal Scientist/Engineer

We are seeking a highly skilled Principal Scientist/Engineer to join our Device and Product Performance team on a permanent basis.

Responsibilities:
  • Provide subject matter expertise to support the development of Combination Products.
  • Plan and execute design verification and reliability strategies.
  • Be the technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are compatible and align with device development.
  • Responsible for the development of design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements.
  • Develop test methods and specifications to assess device functionality and product performance including evaluation, procurement & implement new, state-of-the-art lab testing equipment as applicable.
  • Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification.
  • Provide technical support to manufacturing sites during filling and assembly process development by providing device controls and sampling plans.
  • Use statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations and verification, and reliability.
  • Ensures all activities within team are conducted and executed to the appropriate quality standards within the Quality Management system.
  • Lead support activities for external and internal audits and inspections as applicable.

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