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Director, Software

Summary:

Neural Analytics, a U.S. based medical device company, is searching for a Director of Software. 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:

Provide leadership to the software development teams
Work with Program Management to provide product development teams with appropriate software resources to perform scoped tasks
Work with Software leads to establish software development plans and schedules and facilitate execution of plans through the Software leads on product development objectives for all product development projects involving software
Responsible for ensuring the software development teams follow Design Control procedures per ISO13485, IEC 62304 and 21 CFR 820
Responsible for ensuring Software leads deliver on software performance requirements and specifications for product development programs
Support research programs when necessary
Researching new types of design solutions and processes
Hires and retain highly qualified staff and provide ongoing performance feedback and mentoring. Set goals for the department that align with the company’s and Engineering departments overall Annual Operating Plan. Maintain a professional and effective work environment.
Interface with internal and external development as well as regulatory, quality and marketing resources to ensure the development programs meet regulatory and customer requirements
Develop guides and internal work instructions for software development.
Review and approve project design control deliverables including Software Requirement Specifications, Software Test Plans and Procedures
Interface with appropriate resources to ensure intellectual property is appropriately protected

Requirements:

Skills

Use MS Word, Excel and project tracking software such as MS Project
Use requirements management systems, issues tracking systems (ex. JIRA) and configuration management systems (ex. GitHub)
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.
7 to 10 years of experience in the medical device field
Must have proven track record of launching a 510(k) or PMA supplement product
Experience managing software development resources across multiple programs
Strong organizational, planning and follow-up skills with the ability to hold others accountable
Ability to work effectively in a fast-paced changing environment
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully and mentor direct reports

 

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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