• Extensive experience and intimate knowledge in SW development for medical devices.
• Track record in medical device design from concept to productization
• Expert in Low-Power Software Development
• Experience in design for reliability, testability, and manufacturability
• Experience using multiple software development, modelling tools and bug tracking tools
• Seasoned knowledge of the software/hardware development life cycle including planning, risk analysis, requirements, architectural design, development, verification and validation testing
• Experience in Verification and Validation of Software for medical devices
• Demonstrated skills in IP generation through granted patents
• PhD or equivalent in experience
• Experience in architecture, design and modelling using different operating systems
• Experience with quality management systems for Class III medical devices
• Experience in Class III medical devices
• Experience and knowledge with medical product industry and specifically Medical Software Safety regulations from the FDA, IEC, AAMI, IEEE, and ISO working in regulated medical products industry required
** We will provide relocation support where applicable, final working location is likely to be US West Coast - TBC **
The successful candidate will join the Bioelectronics R&D and Neuromodulation Devices team and will be accountable for:
• Defining strategy and associated budget on the development of software for miniature neuromodulation devices and its external accessories
• Translating user requirements into systems specifications
• Specifying, architecture, and design medical device software
• Select and hiring work force to develop critical parts of software system.
• Implementing Design for Testability, Manufacturability, and Reliability for commercialization.
• Responsible for Verification and Validation of Software
• Interacting with Quality Engineering
• Adopting best practices and standard way of working towards the certification of our devices for human use.
• Working with Quality Engineering and Regulatory team and ensure the compliance of our neuromodulation devices with standards
When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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