ShanMukha Innovations Private Limited
Location
Bangalore | India
Job description
Job Summary:
As an Electrical and Electronics Designer specializing in medical device development, you will be responsible for designing, developing, and testing electrical and electronic components and systems for medical devices. You will collaborate with cross-functional teams including engineers, software developers, and clinicians to ensure that the electrical and electronic aspects of medical devices meet quality, safety, and regulatory standards.
Responsibilities:
Electrical and Electronic Design: Design and develop electrical and electronic circuits, systems, and components for medical devices, ensuring compliance with design specifications and regulatory requirements.
PCB Design: Design printed circuit boards (PCBs) for medical devices, including schematic capture, layout, and routing, using PCB design software (e.g., Altium Designer, Cadence Allegro).
Prototype Development: Create prototypes of electrical and electronic components and systems for testing and evaluation purposes, ensuring adherence to design specifications and functional requirements.
Design Verification and Validation: Conduct design verification and validation activities to ensure that electrical and electronic designs meet regulatory requirements and performance specifications.
Embedded Systems Development: Develop embedded systems and firmware for medical devices, including microcontroller programming and sensor integration.
Software Integration: Collaborate with software developers to integrate electrical and electronic components with software applications and user interfaces for medical devices.
Regulatory Compliance: Ensure that electrical and electronic designs comply with relevant regulatory standards (e.g., FDA regulations, IEC 60601) for medical devices.
Risk Management: Participate in risk management activities related to electrical and electronic design aspects, identifying and mitigating potential risks associated with electrical and electronic components and systems.
Documentation: Prepare and maintain detailed documentation of electrical and electronic designs, including schematics, PCB layouts, firmware code, and technical reports, in compliance with regulatory requirements.
Supplier Collaboration: Collaborate with external suppliers and manufacturers for the procurement of electrical and electronic components and materials, ensuring quality and compliance with design specifications.
Testing and Analysis: Conduct electrical and electronic testing, analysis, and simulation to evaluate the performance, reliability, and safety of electrical and electronic components and systems.
Training and Support: Provide training and technical support to internal teams and external partners on electrical and electronic design-related matters.
Qualifications:
Bachelor's degree in Electrical Engineering, Electronics Engineering, or related field (Master's degree preferred).
Proven experience in electrical and electronic design, preferably in the medical device industry.
Proficiency in PCB design software (e.g., Altium Designer, Cadence Allegro) and other relevant design tools.
Strong knowledge of regulatory requirements and standards for medical devices (e.g., FDA regulations, IEC 60601).
Experience with embedded systems development and microcontroller programming.
Familiarity with software development and integration processes.
Excellent communication and collaboration skills.
Strong problem-solving abilities and attention to detail.
Ability to work effectively in a cross-functional team environment.
Knowledge of risk management processes for medical devices is a plus
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