Skillety
Location
Bangalore | India
Job description
• Develop Embedded software in C, C++ for 32-bit microcontrollers
• RTOS and multithreading experience in embedded software development
• Develop and change-manage various levels of software requirements for medical devices (System and Module level)
• Work with stakeholders to identify and assess product risks (frequency, certainty, severity, and mitigations). Must have the ability to think clearly to root causes and make logical decisions. Should have the ability to recommend, convince, and implement the most pragmatic solutions.
• Evaluation and select system hardware and software architectures, designs, and parts. Ensure that they support all clinical/functional, operational, & financial requirements as well as overall product quality. Make definite recommendations and decisions via trade-off analyses.
• Involve in all aspects of software development cycle for medical devices in accordance with IEC62304
• When assigned, define architecture of the software, involve in risk assessment and failure mode analysis, develop code, review test plans and V&V results.
• Working knowledge of PCBA design, reading EE Schematics, understanding 3D product models and work with the hardware engineering team
• Working with internal and external partners including marketing & product management, systems engineering, project management, hardware engineering, supply chain, manufacturing, QA/RA, V&V teams
Skill / Experience
• Must have experience in launching at least 1 product from concept to commercialization
• Around 8+ (for Lead) ( 1 position ) and 5+ years (for Senior) ( 2 positions) of experiences in Medical Devices R&D (with exposure in FDA 21 CFR Part 820, ISO 62304)
• Extremely hands-on in rigging up systems to make the software run/test the software
• Preferable: Experience in GUI design (Andriod)
• Experience with Board bring up (Boot Loaders & Driver SW)
• Develop and test driver SW (Nand Flash, SPI, I2C, UART, USB, Bluetooth Low Energy)
• Familiar with working with Oscilloscopes, Logic Analyzers etc.
• Very good in algorithm development/understanding
• Understanding of basic physics of fluid simulation (flow, pressure, resistance)
• Understanding of regulatory frameworks, Codes and Standards related to medical device commercialization
Education
• Bachelors/Masters in Software or Electronics Engineering or related discipline
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