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Lead Software Project Engineer

Summary:

Neural Analytics, a U.S. based medical device company, is searching for a lead software project engineer. We are looking for a proven, experienced engineer to help lead a team of software engineers. This individual will work at our corporate headquarters in Los Angeles, California, USA, to direct development of innovative, medical device, and cloud-based medical technology.

Responsibilities:

  • Lead the software designs for product development programs
  • Responsible for Design Control deliverables per ISO13485, IEC 62304 and 21 CFR 820
  • Responsible for the software performance requirements and specifications for product development programs
  • Interface and manage external software engineering projects
  • Support research programs when necessary
  • Works independently with minimal direction from senior management
  • Researching new types of design solutions and processes
  • Create specifications, work instructions and procedures
  • Perform risk analysis and design failure modes and effects analysis
  • Assist with manufacturing production design transfer as well as manufacturing support (when needed)
  • Design, support and/or execute V&V testing for regulatory submissions
  • Document design work and testing sufficient for regulatory submissions
  • Contribute documentation and present design reviews
  • Support product failure analysis and field support
  • Manage team of software engineers
  • Hands on building and testing of prototypes or concepts

Requirements:

Skills

  • Use MS Word, Excel and project tracking software such as MS Project
  • C, C++, C# are required
  • Python nice to have

Education/Experience

  • Must have Software Engineering Bachelor’s degree from an accredited institution; Master’s preferred; PhD a plus
  • 10-15 years of professional hands on engineering and working experience.
  • 3 to 5 years of experience in the medical device field
  • Must have proven track record of launching a 510(k) or PMA supplement product
  • Can work with little to no supervision
  • Medical device software/firmware experience required

 

About the company:

Neural Analytics, Inc. is an LA-based medical device company that is addressing a global unmet need for immediate and non-invasive diagnosis of brain disorders, including stroke, dementia and trauma. The company was formed in 2013 and has been cultivating its cutting-edge technology for the past 3 years.  Neural Analytics is an agile and energetic workplace, staffed by a growing, high-performing team.

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