Device Development Leadership Opportunity

1 week ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €140,000 - €170,000
Lead Device Development Specialist

We are seeking a highly skilled Lead Device Development Specialist to join our team. This is a permanent position that requires expertise in device development, regulatory standards, and quality management.

Key Responsibilities:

  • Develop and implement design verification and reliability strategies for combination products.
  • Provide technical leadership and support to the drug product and device teams during combination product 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.
  • 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.
  • Use statistical techniques or data analysis to inform design decision making and conclusions for deliverables like test method validations, design characterizations, and verification.
  • Ensure all activities within the team are conducted and executed to the appropriate quality standards within the Quality Management system.

Requirements:

  • Master's degree in Science/Engineering.
  • 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.
  • 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 while taking responsibility for individual tasks in a Subject Matter Expert role.
  • Well-developed communication skills to lead or facilitate effective discussions.

Benefits:

  • This is a permanent position.
  • Some travel will be required as part of this role.

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