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Lead Project Software Engineer 10/8/2017

Digital Intelligence Systems, LLC Los Angeles, CA

Los Angeles, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)



BHJOB8895_101439 Title: Lead Software Engineer
Location: Los Angeles, CA
Term: direct hire
Salary: $90k to $120k

DISYS is seeking a Lead Software Engineer to support a research informatics company in Los Angeles CA.

Ideal candidate will be familiar with ISO13485, 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 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

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 @ to contact us if you are an individual with a disability and require accommodation in the application process.