Senior Medical Device Development Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeMedical Full time €90,000 - €122,000

Job Title: Senior Medical Device Development Specialist

This role is for a highly skilled specialist to join our team on a permanent basis.

The position involves leading the design, development and performance evaluation of drug-device combination products ensuring they meet regulatory standards.

  • Provide technical expertise to support the development of Combination Products
  • Plan and execute design verification strategies
  • Be the interface between teams during product development ensuring formulation and manufacturing activities are compatible and align with device development
  • Develop test methods and specifications to assess device functionality and product performance
  • Responsible for material assessment of device components including biological evaluation
  • Provide technical support to manufacturing sites during filling and assembly process development by providing device controls
  • Use statistical techniques or data analysis to inform design decision making and conclusions for deliverables like test method validations and design characterizations
  • Ensure all activities within the team are conducted to the appropriate quality standards within the Quality Management system

Key Responsibilities:

  • Design and develop medical devices in accordance with regulatory requirements
  • Conduct research to identify new technologies and apply them to medical device development
  • Collaborate with cross-functional teams to ensure timely completion of projects
  • Provide expert advice to internal stakeholders on medical device development best practices
  • Maintain up-to-date knowledge of industry developments and emerging trends

Requirements:

  • Degree in Science/Engineering (Master's preferred)
  • 7+ years' experience in pharmaceutical and/or medical device development
  • Working knowledge of regulatory requirements 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 motivated individual who can work as part of a dynamic team

What We Offer:

  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • A collaborative and dynamic work environment

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