Description
Novartis Diagnostics, headquartered in Emeryville, California, is the established global leader in blood safety, a position built on more than 20 years of scientific excellence, ongoing innovation, and collaboration with our development partners. Worldwide, more of the 89 million units of donated blood are tested with Novartis than any other NAT system. But there's still more work to be done to address unmet medical needs. Building on its strong presence in transfusion medicine, Novartis Diagnostics is creating innovative diagnostics to detect, prevent and predict disease and to improve medical outcomes.
The Senior Systems Engineer in the Systems Integration & Engineering team shall develop and support in-vitro diagnostics (IVD) systems with an emphasis on software based projects. As a development lead in cross-functional project teams, he/she shall work as a subject matter expert in solving in-depth and cross-functional problems and/or scientific and technical challenges by utilizing expertise in software development, networking and systems engineering.
• Lead development of software, from requirements through design, implementation, and validation and release to customers.
• Contribute to the architecting of software systems solutions for in-vitro diagnostics systems and interfaces to other diagnostic lab systems and LIS.
• Contribute to the drafting and review of software development agreements with outside partners and vendors.
• Manage outside partners and vendors work and progress towards developing software products, including prototype testing, defect reviews, design reviews, V&V and UAT.
• Develop system level product requirements and component requirement documents using requirements management methodologies including change management.
• Partner with Global Marketing to develop customer requirements; work with other internal stakeholders to facilitate the collection of business and regulatory requirements.
• Define and prepare a schedule of development tasks.
• Conduct patient safety risk management activities according to FDA and ISO regulations.
• Establish product configuration management.
• Plan and perform integration testing.
• Support verification and validation activities.
• Document and present work product to project team and business stakeholders.
• Mentor others on software engineering best practices and procedures.
* B.S. degree in Computer, Engineering or related sciences degree.
* 8+ yrs experience in design verification or validation
* 4+ yrs experience with product development per FDA design control and ISO13485
* Experience creating verification and validation plans, protocols, and reports
* Experience with requirements management, risk based testing approaches, defect tracking, and configuration control tools
* Understanding of good engineering practices and test methodologies
* Capabile of solving technical and scientific problems of medical equipment or other equipment experience involving complex, multi-component systems, including lab automation
* Experience with automation tools for testing applications
* Familiar with engineering process improvement methodologies
* Demonstrated abiility to manage multiple tasks and priorities simultaneously and adapt to changes in program priorities
* Excellent communication and interpersonal skills
Requirements
See Job Description
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