Validation Scientist

Job Summary:

The System V&V Scientist for IVD Products will be responsible for managing and executing the verification and validation processes for the development of innovative in vitro diagnostic products. Such product will typically consist of reagents used on diagnostic instruments. This individual will ensure that our systems (reagent instrument) meet regulatory standards, function properly, and perform as documented in their respective claims (analytical and clinical). This applies to newly developed, complete IVD systems (reagent instrument) as well as the combination of existing assays on open systems.

The ideal candidate will possess a strong background in V&V applied to systems solutions in the IVD world and be capable of handling both the protocol generation, their execution and analysis. The ideal candidate will possess a vast understanding of the assay/reagent side of the system as well as the hardware/software (instrument) side of the system and their combined impact on the IVD performance.

Qualifications:

Education:

• Bachelor's or Master's degree in Biomedical Engineering, Life Sciences, Systems Engineering or a related field.
• Advanced degree preferred.

Experience:

• Minimum of 5-7 years of experience in V&V, or a related role within the IVD or medical device industry.
• Proven track record in managing and executing V&V activities for IVD products, ideally complete systems.

Technical Skills:

• Strong understanding of V&V methodologies and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IVDR).
• Experience with statistical analysis and software tools for data analysis.
• Familiarity with diagnostic instruments and reagent systems and their combined interactions with each other.
• Knowledgeable in reliability, robustness and environmental testing; both from the instrumentation and assay perspective.
• Knowledge of software validation and automated testing tools.

Soft Skills:

• Excellent project management and organizational skills.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.
• Ability to work independently and manage multiple tasks simultaneously.

Job Related Activities:

Develop and Implement V&V Strategies:

• Design, implement, and manage comprehensive V&V plans for IVD systems.
• Knowledgeable about reliability, robustness and environmental testing,
• Ensure V&V processes align with regulatory requirements (e.g., FDA, ISO 13485, IVDR).

Execution of V&V Activities:

• Conduct all V&V activities including test planning, protocol development, test execution, data analysis, and reporting.
• Develop and maintain detailed documentation of all V&V activities and results.
• Generate validation reports, summary reports, and other necessary documentation for regulatory submissions. Protocols and reports should be generated using QS-approved SOPs and generated according to our current QMS guidelines.
• Manage a list the potential bugs discovered during the V&V activity and classify them for decision.

Regulatory Compliance:

• Ensure that V&V activities comply with relevant regulatory standards and guidelines.
• Stay current with changes in regulatory requirements and update V&V processes accordingly.
• Ensure traceability and coverage of testing vs intended used.
• Perform risk assessments and manage risk throughout the V&V process.
• Implement risk mitigation strategies as necessary.

Efficiency:

• Optimize testing to efficiently complement the tests that were done upstream specifically on the reagents and the instrument (HW and SW).

Cross-Functional Collaboration:

• Interact directly with instrument/software manufacturers to program/optimize/troubleshoot/correct any hardware/software anomalies so that they are corrected to our satisfaction.
• Work closely with cross-functional teams (R&D, Commercial, Quality, Regulatory Affairs, Manufacturing) to ensure cohesive V&V strategies.
• Communicate V&V results and issues to stakeholders effectively.