Stability, Verification

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Supports the aspects of data acquisition for various in-house and field programs for current product support (CPS) and new product development (NPD).

Position Overview: Under the supervision of the Manager, Stability, Verification & Validation (Handheld), the Stability, Verification & Validation Test Technician Level 1 supports the aspects of data acquisition for various in-house and field programs for current product support (CPS) such as Sensor Calibration, Lifetime, Proficiency Testing (post-market surveillance) and Field Performance Evaluations, as required. Participates in activities towards new product development (NPD) such as verification and validation activities throughout the product lifecycle management process, assay performance evaluation including stability and shelf-life of consumables and new products development, and regulatory submittal support activities for in vitro diagnostics (IVD) instruments and consumables of blood gas products.

Tests cards in a timely and accurate manner for the purpose of product verification, product calibration, monitoring of ongoing product performance and facilitation of product or sensor calibration process improvements. Is familiar with operational procedures for card testing and is capable of more complex or involved versions of those procedures to determine root causes in the case of product issues. Regularly interacts with Research and Development, Technical Operations, and Quality Assurance personnel.

Responsibilities:

• Participates in daily operations of the Stability, Verification & Validation Lab, including inventory and maintenance for necessary equipment, organization of sample preparations/donors, and assists other laboratory personnel.
• Carries out timely and accurate testing of cards for design verification and validation studies, sensor calibration, lifetime, proficiency testing, and field performance evaluation of NPD and CPS projects.
• Provides detailed annotation for all test results (data acquisition activities) so that engineering analysis can proceed effectively.
• Executes sample preparation procedures and assist with management of raw material inventories to ensure card testing is reliable and uninterrupted.
• Identifies process improvements opportunities related to in-house testing programs such as sensor calibration and lifetime.
• Communicates product performance issues or idiosyncrasies discovered during testing in a timely manner.
• Supports Assay Performance Evaluation in NPD and CPS, Quality Assurance and other groups as required.
• Collaborates with team members and other stakeholders to ensure high quality completion of the team deliverables.
• Supports team members to increase team performance, resolving any impediments where applicable.

Required Knowledge/Skills, Education, and Experience:

• Undergraduate degree in relevant scientific majors, such as Medical Laboratory Technology, Biomedical Laboratory Technology, Clinical Laboratory Technology and/or an equivalent combination of education and technical experience.
• Minimum of 1 year of industrial experience, preferably in laboratory environment.
• Demonstrated knowledge and skill in the use of data collection and analysis programs (e.g., Excel).
• Experienced in maintenance and troubleshooting of laboratory equipment.
• Attentive to details and an ability to follow both the letter and intent of written procedures.
• Willingness to speak up about issues and to provide possible solutions.
• Ability to understand all aspects pertaining to the operation of the epoc blood analysis system and utilize that knowledge to troubleshoot issues related to sample preparations, testing protocols, process workflows and product performance.
• A strong ability to work well in a team setting and commitment to support others.
• Excellent written and verbal communication skills.
• Ability to work with blood samples on a regular basis.

Preferred Knowledge/Skills, Education, and Experience:

• Experience with testing of epoc cards.
• Experience in a regulated industry such as pharmaceuticals or medical devices.
• Demonstrated knowledge and skill in the use of Microsoft Word and Excel.