The Systems Engineering Lead will utilize an interdisciplinary approach, focusing on customer needs and requirements, and work closely with the development team to design, develop, document and test various software solutions ranging from medical mobile apps to medical grade cloud-based systems. This position also helps lead the development team from the ambiguity of voice of customer through verification and validation in order to arrive at the best possible solution in a compliant, high quality, and timely manner. This position is responsible for aspects related to product design, development, and maintenance, with focus on requirements, system architecture, product risk analysis, usability, change control, and product support for digital products running on the BrightInsight platform. The BrightInsight platform is a medical IoT cloud-based platform for the life science industry, and is used to manage, process, and store patient health and medical device data to be used for patient diagnosis and treatment.

We are looking for someone who thrives in a start-up environment and demonstrates:
• Relentless drive to win and bring a product to market
• Start-up mentality to wear multiple hats and do what’s required to get the job done
• Passionate customer focus

Here is a glimpse of what you’ll do:
• Interprets customer, business, and compliance needs to define technical design requirements
• Identifies essential and critical requirements, and effectively trace requirements to design and test cases
• Leads definition of high quality and comprehensive system verification and validation strategy
• Leads risk analysis activities, including hazard analysis, FMEA, FTA, and risk-benefit analysis
• Leads design reliability and strategy

Here is some of what you’ll need (required):
• 7+ years of software-based medical device systems experience
• Experience providing technical leadership
• Experience launching medical device solutions
• Understands FDA human factors guidance and IEC standards
• Deep understanding of ISO 13485, ISO 14971, IEC 60601, IEC 62366, FDA 21 CFR Part 820, FDA 21 CFR Part 11, FDA design control guidance, cybersecurity requirements, and FDA human factors guidance, and application to software-based medical devices
• Familiarity with health and data privacy regulations

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