This position involves synthesizing customer needs, business needs, and technology expertise into a software system design and product development and implementation plans for the next generation of Inspire products. This position will also provide functional technical input for therapy and product system design as well as support continuation engineering as required.
- Provide software expertise for new products as well as changes to existing products
- Engage in software design reviews for products in development as well as continuation
- Designs, develops, tests, debugs and implements operating systems components, software tools and utilities.
- Determines systems software design requirements.
- Ensures that system improvements are successfully implemented and monitored to increase efficiency.
- Generates systems software engineering policies, standards and procedures.
- Design, implement, test, debug and document integration solutions and enhance existing components to ensure that software meets the business needs, while in compliance with applicable regulations and processes.
- Conduct design and code reviews to ensure code developed meets or exceeds coding best practices guidelines, unit testing, security, and scalability and maintainability guidelines.
- Assure compliance with industry applicable standards for medical devices
- Ensure all quality system, regulatory, legal, and business requirements are met in the course of product development and market delivery
- Create, control and store software source and executable code.
- Support Inspire customers as assigned
- Bachelor’s degree in software or electrical engineering or related field.
- Master’s degree in software or electrical engineering or related field.
- Minimum of 8 years of work experience in software development
- Experience designing, developing, and delivering innovative software technology.
- Ability to efficiently specify, code, test, and deploy high quality software
- Experience in developing and deploying highly secure cloud services.
- Knowledge of state of the art security architectures and implementations
- Experience developing software in C#, C, Swift, Python and other languages.
- Active implantable medical product development experience
- Experience with web application deployment using Azure Platform as a Service
- Understanding of software and/or firmware development, testing and the corresponding standards
- Understanding of usability standards and integration of them into the product development process
- Experience with manufacturing process validation activities (IQ/OQ/PQ)
- Experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.
- Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing