Systems Engineer - II
Device Requirements Analyst This position will assist an R&D department requirements engineer with gathering, sorting, analyzing, and properly documenting various forms of design input toward the goal of producing consistent, clear, and complete Product Requirements Documents for upcoming medical device products. Design input will include such sources as complaint files, letters, emails, preliminary requirements documents, Internet and literature searches, business requirements, domestic and international regulatory requirements, and input from areas such as clinical, human factors, environmental, supply chain, production, and other stakeholders. It is expected that some input will be contradictory or incomplete or that some items may require further research or escalation. Assistance will be available as needed. The successful candidate will possess at least a BS in an engineering discipline and at least 3 years relevant experience. The candidate must be able to elicit input from technical and non-technical people in a positive and unbiased manner. Direct experience with processing of medical device requirements is highly desirable. Experience with requirements management tools such as Doors or Caliber is a plus. Thanks and Regards, Srikanth Arveti Infobahn Softworld Inc Ph:703-672-2327 firstname.lastname@example.org http://www.infobahnsw.com
WEST CHESTER, PA
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