Lead Project Software Engineer
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POST DATE 10/8/2017
END DATE 1/8/2018
Digital Intelligence Systems, LLC
Los Angeles, CA
JOB DESCRIPTIONJOB DESCRIPTION
BHJOB8895_101439 Title: Lead Project Software Engineer
Location: Los Angeles, CA
Term: direct hire
Salary: $95k to $125k DOE, plus stock options
DISYS is seeking a Lead Project Software Engineer to support a medical research informatics company in Los Angeles CA.
Ideal candidate will be familiar with ISO 13485, IEC 62304 and 21 CFR 820 standards; skilled in C, C++ and C#; experience launching 501(k) and/or PMA supplement products; and medical device software / firmware experience.
* Lead the software designs for product development programs
* Responsible for Design Control deliverables per ISO 13485, 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
* Use MS Word, Excel and project tracking software such as MS Project
* C, C++, C# are required
* Python nice to have
* 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
* Understanding of ISO 13485, IEC 62304, 21 CFR 820 and/or FDA regulation.
* Can work with little to no supervision
* Medical device software/firmware experience required
* Must have Software Engineering Bachelor s degree from an accredited institution; Master s preferred; PhD a plus
Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.