Location
Bangalore | India
Job description
- Develop Embedded software in C, C++ for 32-bit microcontrollers 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
Requirements:
- Bachelors/Masters in Software or Electronics Engineering or related discipline Around 5-7 years 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
- Experience with Board bring up (Boot Loaders & Driver SW)
Preferable:
- Experience with Operating Systems (Linux, Ubuntu) Develop and test driver SW (Nand Flash, SPI, I2C, UART, USB, Bluetooth Low Energy)
- Familiar with working with Firmware tools such as Oscilloscopes, Logic Analyzers etc
- Very good in algorithm development/understanding
- Understanding of regulatory frameworks, Codes and Standards related to medical device commercialization
Note: Customer is looking design/ development experience along with any medical background.
Job tags
Salary
