Job Description

Job Summary: We are seeking a skilled Electronics R&D Engineer to join our team focused on the development of innovative medical devices. The ideal candidate will have hands-on experience in electronic testing and a strong background in converting electronic designs into manufacturable products. Key Responsibilities: Design and Development: Create and develop electronic systems and components for medical devices, ensuring they meet specified requirements. Prototyping and Testing: Build prototypes, conduct rigorous testing, and validate designs to ensure functionality and compliance with industry standards. Manufacturing Transition: Collaborate with manufacturing teams to convert existing electronic designs into production-ready formats, including assembly instructions. Documentation: Write detailed protocols, test plans, and populate test results to support regulatory submissions. Regulatory Compliance: Ensure designs adhere to IEC 60601 standards and ISO 13485 quality management systems. Cross-Functional Collaboration: Work closely with cross-functional teams, including hardware, software, and quality assurance, to define project requirements and solve technical challenges. Qualifications: Education: Bachelors degree in Electronics Engineering / Electrical Engineering. Experience: 4-6 years of relevant experience in electronics design and development, specifically within the medical devices sector. Technical Skills: Proficient in eCAD software for circuit design (e.g., Orcad / Mentor Graphics). Hands-on experience with electronic testing equipment and techniques. Strong understanding of electronic circuits and components. Well versed with obsolescence mgmt. Regulatory Knowledge: Familiarity with IEC 60601 standards and ISO 13485 requirements is essential. Communication Skills: Excellent verbal and written communication skills; ability to document processes clearly for regulatory submissions. Must Skills: Experience in hardware prototyping techniques. Assembly & Testing of complete unit / device. Ability to manage documentation needs for regulatory submissions effectively. Strong analytical skills with attention to detail in problem-solving.