Website Avivomed
REQUIREMENTS:
- BS or MS in electrical engineering, computer engineering, computer science, or equivalent.
- 10+ years professional experience in implantable medical device firmware development, with 5+ years in a senior R&D role.
- Expertise in implantable medical device firmware development, including working directly with target hardware, sensors, wireless RF communications, data security, power management and profiling.
- Expertise in the software development lifecycle, software documentation and deliverables.
- Expertise in configuration management, automated testing, and software verification and validation.
- Experience with real-time operating systems, or Linux/Windows kernels.
- Expertise in computer science principles such as object-oriented design, data structures and programming in C, C++, C#, Python, or similar programming languages.
- Experience with signal processing and algorithm development.
- Good interpersonal, written, and verbal communication skills.
- Deep knowledge of IEC 62304, ISO 14971 and other industry standards applicable to medical device software development.
- Demonstrated ability to interface with electrical, mechanical, software, and biomedical engineers and work in a fast-paced, multi-disciplinary environment
RESPONSIBILITIES:
- Lead the design and analysis for the embedded firmware for an implantable neurostimulator. Analyze software requirements, interfaces, components, and technologies.
- Lead the development of the firmware code, according to established quality standards.
- Develop and author the document deliverables for the firmware, including requirements, design documents, risk analyses, and V&V testing strategies.
- Lead implantable neurostimulator firmware code and design reviews, document the results, track, and monitor action items.
- Lead system integration, build and release activities.
- Work closely with software V&V engineers to assure firmware functionality and performance.
- Lead the bug tracking process, including the management, cross-functional review, tracking, and follow-up.
- Work with senior technical team to define and accomplish development objectives.
- Provide detailed support for clinical studies and regulatory submissions.