IT-Software Development: Computer-Network Security, Database Development-Administration, Desktop Service and Support, Enterprise Software Implementation & Consulting, General-Other: IT-Software Development, IT Project Management, Network and Server Administration
Responsibilities •Read and understand customer and product requirements.
•Work in a team environment to author and implement V&V protocols using peer review process.
•Design and conduct studies to validate performance characteristics of hematology products. Review and analyze performance data and create review summary of tests.
•Conduct technical reviews of test data and create verification and validation summary documents.
•Familiarity with regulatory and ISO requirements is a plus. Med tech experience is a plus.
Skills required: •0-2 years relevant Medical Device V&V experience in an FDA-regulated.
•knowledge in biological and diagnostics systems, preferred
•Customer focused; Excellent oral, written communication and interpersonal skills
•Excellent written communication skills; the ability to articulate complex technical concepts and issues in a simple, easy to understand manner.
•Must be able to interact effectively and work well with team members under stressful conditions.
Education Requirement: •Knowledge of regulations and standards affecting IVDs and Biologics. B.S. in a life or physical science or engineering
San Jose, San Francisco CA
Phone: (866) 816-1615 x 823