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Sr. System Engineer, Automation

Novartis Vaccines & Diagnostics, Inc.

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Location: Emeryville, CA Posted Date: 4/18/2013 Position Type: Full time Job Code: 3627688HHL Salary: Competitive Required Education: Bachelors Degree Areas of Expertise Desired: Research

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 will develop and support automated in-vitro diagnostics (IVD) systems and software. In cross-functional project teams, he/she shall work as a subject matter expert in architecting, developing and commercializing IVD systems including automation and robotics by utilizing expertise in systems engineering.

* Perform systems development of automated solutions, from requirements through design, implementation, and validation and release to customers.
* Develop system level product requirements and component requirement documents using requirements management methodologies including change management.
* Work with Global Marketing to assess customer needs and develop customer requirements; work with other internal stakeholders to facilitate the collection of business and regulatory requirements.
* Utilize VOC and Requirements Management techniques to ensure correct requirements are captured and traced to specifications
* Develop and maintain design control documentation: requirements, architectures, specifications, configuration management, traceability and change management for development projects.
* Contribute to the architecting of hardware and software systems solutions for in-vitro diagnostics systems and interfaces to other diagnostic lab systems and LIS.
* Work with marketing team and OEMs to develop automation solutions.
* Contribute to the drafting and review of development agreements with outside partners and vendors.
* Oversee outside partners and vendors work and progress towards developing products, including prototype testing, design reviews, V&V and UAT.
* Define and prepare a schedule of development tasks, scopes, deliverables and timelines. Track progress against plan, communicating progress reports (to team, project/program manager)
* Conduct patient safety risk management activities according to FDA and ISO regulations.
* Plan and perform integration testing.
* Support verification and validation activities.
* Document and present work product to project team and business stakeholders.
* Mentor others on systems engineering best practices and procedures.

* B.S. Degree in Engineering and/or Science: advanced degree preferred.
* 9+ years of systems engineering experience developing diagnostic products.
* 3+ years' experience developing automated track or robotic solutions.
* Experience with leading development efforts in a cross functional environment.
* Ability with solving complex systems engineering issues and problems, for systems including instrumentation, consumables, assays and reagents.
* Experience with design of experiments and statistical analysis to solve complex problems.
* Demonstrated product development experience using lifecycle methodologies and under FDA design control.
* Ability to convey complex information in both written and oral form.
* Experience with managing external vendor relationships.
* Ability to influence others, gain acceptance and build consensus.
* Excellent communication and interpersonal skills.
* Working knowledge in worldwide IVD regulatory processes and clinical evaluations highly desired
* Knowledge of molecular biology is a plus.

Requirements

See Job Description
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