Senior Electronics Engineer

JOB SUMMARY We are looking for a highly skilled and experienced Senior Embedded Systems Engineer to join our dynamic team. In this role, he/ she will:

• Be responsible for Designing, developing, and maintaining embedded systems and software for medical devices.
• Work closely with cross-functional teams to ensure the successful integration of hardware and software components.
• Be responsible for optimizing system performance, ensuring reliability, and meeting project deadlines.
• Have a strong background in embedded systems, excellent problem-solving skills, and the ability to work independently as well as part of a team.
• Be expected to stay up to date with the latest industry trends and technologies and apply this knowledge to improve our products and processes.
• Independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team.

ESSENTIAL DUTIES

• 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 with experience in budgeting adequate resources and time for execution of the plans
• Create, maintain and release Design History File (DHF), Device History Record (DHR), Device Master Record (DMR)
• Conduct Technical reviews to root cause issues, perform tradeoff analysis, document key design considerations for future reference

OTHER DUTIES AND RESPONSIBILITIES

• Work direction responsibility may include 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.

MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree or equivalent of 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. Experience 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 years of experience for Electronics Engineer. Skills

1. Must be exceptionally good in C/C++ programming, testing/debugging and in advanced C concepts (pointers, structures, unions, interrupts etc.)
2. Strong Knowledge of hardware design in Analog, high frequency Digital Circuit Design and RF circuits design
3. Experience with I2C, SPI, UART, USB, Ethernet, BL/BLE On Micro-Controllers (preferably ARM)
4. Good amount of core experience in the field of embedded systems design and programming or must have completed 6 months certified course in C programming/Embedded systems
5. Must have completed a number of Embedded Systems based projects based on 8/16/32 bit microcontrollers preferably for medical equipments
6. Good knowledge of using tools like C/C++ cross compilers for microcontrollers. (GCC/Keil/MCUExpresso)
7. Driver development in Linux SBC environment preferable
8. Experience with resource limited Embedded RTOS or Embedded Linux in SBC
9. Proficient with PCB design tools or EDA Software (Altium or OrCAD)
10. Experience Implementing and Testing Device Drivers for Linux/Win In C, Embedded C, C++
11. EMI/EMC and safety standards for medical equipments and test requirements
12. Experience in DFMEA and Risk analysis and product development life cycle

PHYSICAL REQUIREMENTS 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. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements Requires travel based on business needs.