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

Los Angeles, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree



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.