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- 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.
- 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.
- 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.
