Software Engineering Manager Micronics
The Software Engineering Manager is responsible for leading the development of embedded software that will control the company?s in vitro molecular diagnostic platform instruments. The Software Engineering Manager will report to the company?s VP Product Development and work closely with other key internal and external team members to ensure that the device?s hardware interfaces and control, user interfaces, and diagnostic and preventative functions operate as intended. This position plays an integral role in the product development process for the platform instrument, assisting in all aspects of the business from the requirements definition, to product launch and support. The Software Engineering Manager will lead a team of internal and external software developers with whom she/he will work closely to build and support all necessary software.
Primary Responsibilities :
?Design, construct and test new embedded software systems that control the molecular IVD platform instruments and all of the biological assays that run on the platform instruments.
?Support existing embedded software systems that control molecular IVD platform instruments.
?Lead the entire software development life cycle process of planning, design, unit verification, integration, validation, release and support.
?Responsible for the documentation efforts for software requirements, testing and version control.
?Provide all information needed for a successful FDA clearance to market or FDA approval and CE IVD approval.
?Deliver error free software that meets its technical and usability requirements.
?This person must have intimate knowledge of and have successfully applied software development principles and methods for embedded systems as described in 1) ANSI/AAMI/IEC 62304 Medical Device Software ? Software life cycle processes and 2) FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and 3) FDA Guidance of the General Principles of Software Validation.
?Expert knowledge of C# and C++ and strong coding capabilities.
?Understanding of GUI framework design and implementation methods.
?Ability to manage multiple projects in different software life cycle phases.
?Capable of writing effective and clear requirements, design and test documents.
?Must be a team leader who produces results and works well in a collaborative team environment.
Experience and Education
?Must have a demonstrated track record of success for a minimum of 8 years in developing and executing embedded software in a medical device or IVD regulated environment
?The majority of projects should have been for software that has a moderate or major level of concern as defined by the FDA.
?Must have been involved with at least one successful 510(k) or PMA submission.
?B.S. degree in computer science is required.
?M.S. degree in computer science is desirable.
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