Senior Electronics Engineer
1 week ago
We are seeking an experienced Senior Electronics Engineer to join our team at Terumo Blood and Cell Technologies. As a key member of our dynamic team, you will be responsible for designing, developing, and maintaining embedded systems and software for medical devices.
Key Responsibilities:- Design and develop embedded systems and software for medical devices
- Work closely with cross-functional teams to ensure successful integration of hardware and software components
- Optimize system performance, ensure reliability, and meet project deadlines
- Stay up-to-date with the latest industry trends and technologies and apply this knowledge to improve our products and processes
- Conduct design change impact assessments, coordinate technical reviews, and conduct failure analysis and risk impact assessments
- Translate user and business requirements into detailed product requirement specifications and design specifications
- Apply design controls with extensive knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development
- Design and develop embedded systems and software for medical devices
- Collaborate with cross-functional teams to integrate hardware and software components
- Optimize system performance and ensure reliability
- Troubleshoot and resolve issues related to embedded systems
- Document design specifications, test procedures, and results
- Stay current with industry trends and technologies
- Participate in code reviews and provide constructive feedback
- Mentor junior engineers and provide technical guidance
- Contribute to the continuous improvement of development processes
- Ensure compliance with industry standards and regulations
- Manage project timelines and deliverables
- Apply Six Sigma and Lean principles to enhance efficiency and minimize waste
- Define integration and verification plans
- Create, maintain, and release Design History Files (DHF), Device History Records (DHR), and Device Master Records (DMR)
- Conduct technical reviews to root cause issues and perform trade-off analysis
- May work direction responsibility for technicians and junior engineers
- May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues
- May contribute to the establishment of business objectives, goals, budgets, and costs
- Bachelor's degree or equivalent education and experience sufficient to successfully perform the essential functions of the job may be considered
- Bachelor of Science degree or Master of Science degree in Engineering preferred
- Minimum of 5 years of experience is required for a Senior Electronics Engineer and minimum 3 years of experience for Electronics Engineer
- Minimum of 3 years of experience in the medical device field preferred for Senior Engineer and minimum 1 year of experience for Electronics Engineer
- Exceptional skills in C/C++ programming, testing/debugging, and advanced C concepts (pointers, structures, unions, interrupts, etc.)
- Strong knowledge of hardware design in analog, high-frequency digital circuit design, and RF circuits design
- Experience with I2C, SPI, UART, USB, Ethernet, BL/BLE on micro-controllers (preferably ARM)
- Good amount of core experience in the field of embedded systems design and programming or completion of 6 months certified course in C programming/embedded systems
- Completion of a number of embedded systems-based projects based on 8/16/32-bit microcontrollers preferably for medical equipment
- Good knowledge of using tools like C/C++ cross-compilers for microcontrollers (GCC/Keil/MCUExpresso)
- Driver development in Linux SBC environment preferable
- Experience with resource-limited embedded RTOS or embedded Linux in SBC
- Proficient with PCB design tools or EDA software (Altium or OrCAD)
- Experience implementing and testing device drivers for Linux/Win in C, Embedded C, C++
- EMI/EMC and safety standards for medical equipment and test requirements
- Experience in DFMEA and risk analysis and product development life cycle
General labor environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds or transporting up to 500 pounds via carts or mechanized equipment.
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