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Product Development-Medical Device Software

Company: Johnson Service Group, Inc.
Location: Oakland
Posted on: February 25, 2021

Job Description:

Our client in Oakland, CA is seeking a Software Systems EngineerTechnical Product Manager for a long-term contract position. This exciting role will have you working on advanced RD product development in the medical device industry. The Software Systems EngineerTechnical Product Manager should have experience in medical software product development with experience dealing with the regulatory, quality and safety aspects, plus experience and thorough understanding of the software development process required by FDA. Responsibilities include bull Foster collaboration with SW product designers, engineers, quality assurance, and marketing to explore, prioritize, and launch solutions. bull Work with the development team to ensure that SW product requirements are understood and built accordingly. bull Translate the SW productrsquos strategy into detailed requirements for final product development. bull Design and define the SW product functionality. This includes defining the user interface and workflow, specification of product metrics and working with RD scientists on the technical specifications for the system. bull Outline the SW product vision, product strategy, and product roadmap. bull Support SW engineering team to ensure development goals are met. bull Use a software development methodology, like Agile, to optimize processes. bull SW Hazard, safety and risk assessment including evaluation of mitigating measures. This includes a broad range of factors including i. Gauge the risk of misunderstanding causing improper use. ii. Evaluating the effects of improper use, e.g. effect of pressing the wrong button. a. Clinical hazards and risk assessment. b. Design failure analysis c. Cyber-security risks Requirements and Qualifications Bachelorrsquos degree or higher in computer science, information technology or related field Evidence of continuing education, such as technical certifications, a plus Experience working in an FDA regulated industry (SW development) is required. Minimum 7 yearsrsquo experience. Local to the Bay Area preferred. Work will be remote during COVID lockdown.

Keywords: Johnson Service Group, Inc., Oakland , Product Development-Medical Device Software, Healthcare , Oakland, California

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