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Sr.Staff Engineer: WorldScape Inc
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You must understand diagnostic product dev under FDA Quality System Regulations for medical devices
Job Description for Outside Posting
Sr. Staff Engineer This is an ideal job for a technical person who has made or is looking to make a transition from a technical contributor to a management role, with many opportunities to have an impact on the long-term success of the company. You will manage the development and validation of diagnostic instruments and software with partner companies; coordinate changes to instrument configuration for validated assays; and explore and assess new instrument technologies. It will be important to develop a thorough understanding of external customer needs for instrumentation and software and to work with our assay development group to understand future instrumentation needs. You may represent the department on project teams and will review project plans to ensure consistency with departmental strategy and for achievability of deliverables and dates. We will also look to you to ensure that the instrumentation you are responsible for is developed and validated in a suitable manner to support FDA assay submissions.
Primary Skill/Knowledge Requirements This job requires knowledge and skills normally acquired through the successful completion of a Ph.D. in engineering, chemistry, biology, or a related discipline; or a Master's degree and equivalent technical experience. We would prefer at least 10 years of work experience, with at least 4 years of relevant experience in instrument development. Success in the job will require strong planning, organization, and communication skills. Some project management experience is required, and demonstrated experience in managing effectively from a position of indirect influence (such as in a consulting role) will be a plus. You must understand diagnostic product development under FDA Quality System Regulations for medical devices, with direct experience with software or instrument development in a regulated environment preferred.
Please send the following information so I can pursue further. For further details please email sonia@worldscapeinc.com or call 510-739-1357
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