Job Title: Electronics Engineer - Medical Devices

Location: Shanmuka Innovations, Bangalore

Job Type: Full-Time/Permanent

About the Role:

We are seeking a highly skilled and motivated Electronics Engineer with expertise in medical device development. The ideal candidate will have a strong understanding of product and design requirements, and be capable of leading the entire electronics design process, from concept through to manufacturing. This role requires experience in developing the electronic architecture of medical devices, creating schematics, designing PCBs. The candidate should also have the ability to write detailed verification plans and guide the team through manufacturing, assembly, and testing phases, ensuring compliance with industry standards and regulations.

Key Responsibilities:

• Understand and translate medical device product and design requirements into electronic designs.
• Develop detailed electronic schematics and PCB layouts using industry-standard design tools.
• Design the electronic architecture of medical devices, ensuring compatibility with other system components.
• Create and maintain documentation, including design requirements, schematics, BOMs, and assembly instructions.
• Develop and execute verification and validation plans, ensuring that all designs meet the required specifications and standards.
• Provide technical guidance and support to manufacturing teams during assembly and testing.
• Lead the process of troubleshooting and resolving issues that arise during development, manufacturing, and post-production.
• Ensure compliance with all relevant regulatory standards (e.g., ISO 13485, IEC 60601).
• Manage the lifecycle of electronic components, ensuring that all aspects of design, manufacturing, and testing are documented and controlled.
• Collaborate with cross-functional teams, including software engineers, mechanical engineers, and quality assurance, to ensure the successful development of the product.

Qualifications:

• Bachelor’s or Master’s degree in Electrical Engineering, Electronics Engineering, or a related field.
• Minimum 8 to 10 years of experience in electronics design, preferably in the medical device industry.
• Proficiency in schematic capture and PCB design tools (e.g., Altium Designer, OrCAD, Eagle).
• Strong knowledge of electronic components, circuit design, and signal integrity.
• Experience in developing and writing verification and validation plans for medical devices.
• Familiarity with regulatory requirements and standards for medical devices (e.g., ISO 13485, IEC 60601).
• Excellent problem-solving skills and attention to detail.
• Strong communication skills and ability to work collaboratively in a multidisciplinary team environment with Product designers, Software, Quality, Regulatory, Vendors, Testing Laboratory .
• Experience with lifecycle management of electronic components in a regulated environment.
• Experienced with battery management systems

Preferred Qualifications:

• Experience with embedded systems and firmware development.
• Knowledge of risk management and failure modes analysis.
• Experience in guiding and mentoring junior engineers.