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US-CA-Foster: Staff Engineer, Bioengineering

Date: 26-Jun-2012
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Staff Engineer, Bioengineering

* Lead verification and validation of product design and performance during the development cycle, from feasibility through product release. Products include instruments, reagents, consumables, procedures, applications for quantitative PCR and automated sample preparation.. * Participate or lead system integration activities including testing, troubleshooting and documentation. * Apply engineering and scientific competencies to develop product requirements and specifications. * Perform risk analysis and implement risk mitigation activities to support the life-cycle of a product. Prepare appropriate technical documentation for product design history files and submissions. * Ensure compliance with requirements of working in a regulated environment including Design Control process and Good Laboratory Practices (GLP). * Ensure activities are consistent with project critical path, and respond to changing priorities. * Frequent contact with external resources and contacts at various management levels concerning scheduling or operations of specific phases of projects. * Manage distinct areas with or without subordinates. * Industry experience in a regulated environment and qPCR systems development experience preferred. * Understanding of GLP, QSR and ISO regulatory requirements for IVD products required. * Led V&V effort beginning with a test plan, and ending with a test report, including tracing and resolution of testing issues. * Experience with integration of a system or procedure, with good troubleshooting skills. * Developed requirements and specifications for complex system/subsystems, including evaluation for coherence and completeness. Able to manage a schedule and coordinate team activities. Familiar with phase-gate product development processes. * Able to influence others in a matrix type organization. Able to build relationships within the project team as well as with management. * Good written and oral communication skills, as well as ability to prepare and communicate technical information to a wide range of audiences. * Highly organized and detail-oriented. * An excellent understanding of molecular biology is a plus. * Project or people management experience is a plus. * BS + 10 yrs experience, MS + 7 yrs experience, or PhD as + 4 yrs experience.

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