Looking for an awesome V&V Team Lead to join the multi-award-winning and exciting MedTech start-up, Donisi Health. Donisi developed the world’s first FDA-cleared technology that remotely detects multiple key health parameters simultaneously and can provide indications for heart failure exacerbation (as well as additional biomarkers) – from the convenience of a patient’s home, free from wires, patches, and wearables.
Reviewing business and technical specifications to write and execute manual test scripts for quality assurance testing. Defining test strategy, executing test plans, reviewing tests product specifications, and participating in defining/selecting appropriate test tools and automation strategy. work closely with SW/HW Program Management, and Operations to test and roll out the releases. Handle and support dynamic schedules, multiple environments, test cycles, and deployments. R&R: Create detailed, comprehensive, and well-structured V&V test protocols and reports, with the ability to maintain and cross-reference it with Risk Analysis Matrix & Design Control documentation. Develop, apply & maintain test methods, equipment and instruments for the medical device throughout all development and production stages of the product to meet user needs & product requirements. Being involved in the reliability and integration tests for prototypes and products. Maintain relevant chapters of DHF & DMR. Review specifications and technical design documents to provide timely and meaningful feedback for V&V activities. Owner & maintain company’s V&V dept. 70% hands-on 30% team lead Development and implementation of methodologies for collecting and analyzing field failure data and determining the root cause of field failures Coordinating failure analysis with other disciplines as necessary to lead to determination of root cause. Ensuring corrective actions are implemented in manufacturing to prevent recurrence of failure. Incorporating automation and improvement of the failure analysis process.
Required Experience & Skills:
Required Personal Skills