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Medical Device Specialist

2 weeks ago

Dublin, Dublin City, Ireland So Code Limited Full time
About So Code Limited

We are seeking a highly experienced Principal Scientist to join our Device and Product Performance team.

This role offers an exciting opportunity to develop Combination Products and collaborate with a multi-disciplinary team to ensure product performance and compliance with industry standards.

The ideal candidate will have:
  • A Master's degree in Science or Engineering
  • Over 7 years of experience in the development of Combination Products
  • 3-5 years of hands-on experience with design control practices, including medical industry standards
  • Expertise in developing and validating analytical testing methodologies
  • Proficiency in applying statistical methods for data analysis
  • Experience in preparing regulatory submissions and ensuring compliance with industry standards
  • Proven experience as a Subject Matter Expert, delivering presentations to both technical and non-technical audiences
Your Key Responsibilities
  • Develop and implement testing strategies to evaluate device performance
  • Collaborate with cross-functional teams to ensure product performance and compliance with industry standards
  • Design and execute strategies for design verification and reliability testing
  • Act as the key technical liaison between drug product and device teams throughout combination product development
  • Provide technical guidance during the development of manufacturing and assembly processes
  • Leverage statistical analysis to support design decisions and test method validations
Benefits
  • A competitive salary and benefits package
  • An opportunity to work with a global leader in the healthcare industry
  • A collaborative and dynamic work environment
  • Ongoing professional development and training opportunities