Medical Device Innovator Lead

1 day ago

Dublin, Dublin City, Ireland beBeeScientist Full time €100,000 - €120,000

Principal Scientist/Engineer Medical Device Development

We are seeking a highly skilled Principal Scientist/Engineer to lead the design, development, and performance evaluation of drug-device combination products.

  • 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.
  • Ensure 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.

Requirements

  • Degree in Science/Engineering (Master's preferred).
  • 7+ years' experience in pharmaceutical and/or medical device development.
  • Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage.
  • Experience in the development and validation of analytical methods.
  • Experienced in application of statistical techniques for data analysis.
  • Experience of writing and supporting regulatory submissions.
  • Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role.
  • Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.
  • Some travel will be required as part of this role.

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