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Diagnostic Systems Specialist

1 month ago

Royston, Barnsley, United Kingdom Oho Group Full time
Diagnostic Systems Specialist

Contribute to the development and refinement of cutting-edge diagnostic systems as a Diagnostic Systems Specialist. This role will be pivotal in perfecting the electronics design of the product as it moves towards launch. You'll work closely with the team and collaborate with an external electronics team to ensure smooth knowledge transfer, design integrity, and technical evaluations.

Key Responsibilities
  • Support verification and validation processes to prepare the system for clinical studies and FDA approval.
  • Implement test plans and protocols, documenting all activities within the Quality Management System (eQMS).
  • Develop Work Instructions and Standard Operating Procedures (SOPs).
  • Collaborate with Engineering, Manufacturing, and Biology teams to achieve regulatory submission and product launch.
  • Ensure compliance with ISO 13485/FDA regulatory requirements.
Qualifications
  • Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices within an ISO13485/21CFR regulated environment.
  • Experience in writing test protocols aligned with Product Requirement Specifications.
  • A degree in Science or Engineering or equivalent relevant experience.
  • Experience in medical device development and commercialization.
Preferred Skills
  • Hands-on experience in an ISO13485/FDA regulated environment.
  • Strong background in developing and executing verification and validation protocols.
  • Ability to collaborate effectively with cross-functional teams.