- Location
- Bengaluru, India
- Department
- IT
- Seniority
- Senior
- Experience
- 7+ years
- Education
- Master
- Source
- Keka
Description
Senior Mechanical Design Engineer
Experience: 7+ Years
Location: Peenya, Bengaluru (Work From Office)
About Remidio
Remidio is a global pioneer in AI-driven eye care, transforming healthcare through innovative ophthalmic equipment and AI-powered diagnostics. As India's first company to receive CDSCO approval for adaptive ophthalmic AI and CE certification under EU-MDR, Remidio is redefining preventive healthcare by enabling early detection of diabetic retinopathy, glaucoma, AMD, and expanding into systemic disease screening, including CVD and CKD.
Our FDA-registered medical devices have screened over 16 million patients across 40+ countries, delivering fast, accurate, and accessible eye care. Founded with a vision to democratize preventive healthcare, Remidio continues to combine cutting-edge innovation with clinical excellence to improve healthcare outcomes globally.
Job Summary
We are looking for an experienced Mechanical Design Engineer with 7+ years of experience in the design and development of Class I & Class II medical devices. The ideal candidate should have hands-on experience across the complete product development lifecycle—from concept generation to commercialization—and possess strong expertise in mechanical design, CAD modelling, prototyping, verification & validation, and design documentation.
The role demands a technically strong, self-driven professional capable of developing innovative electro-mechanical products while ensuring compliance with global medical device standards and design best practices.
Key Responsibilities
- Support the design and development of new medical devices based on customer requirements and defined Critical-to-Quality (CTQ) parameters.
- Design mechanical systems, subsystems, and components using CAD tools while adhering to applicable engineering standards and design guidelines.
- Develop innovative design solutions for complex engineering problems through analysis, evaluation, and creative problem-solving.
- Create detailed 2D manufacturing drawings and manage engineering changes through ECN/ECR processes.
- Participate in Design Failure Mode and Effects Analysis (DFMEA) and product risk assessment activities.
- Collaborate with cross-functional teams including Industrial Design, Electronics, Manufacturing, Quality, and Regulatory Affairs.
- Design components with Design for Manufacturing (DFM) and Design for Assembly (DFA) principles.
- Design and develop production jigs, fixtures, and packaging solutions.
- Support mechanical design verification activities including shock, vibration, reliability, and environmental testing as per product specifications and applicable IEC standards.
- Prepare Bills of Materials (BOM), work instructions, engineering documentation, and technical reports.
- Investigate and resolve product quality issues related to mechanical design and provide technical support to manufacturing teams.
- Participate in NC/CAPA activities and continuous product improvement initiatives.
- Support product launches and CUFT production activities as required.
Technical Competencies
- Experience in medical device product development, preferably for Class I & Class II medical devices.
- Good understanding of ISO 13485, FDA regulations, and applicable medical device regulatory standards. Knowledge of ISO 15004-1 and ISO 15004-2 is preferred.
- Proven experience in end-to-end electro-mechanical product development from concept to commercial release.
- Strong understanding of medical-grade materials including metals, plastics, polymers, and associated manufacturing processes.
- Proficiency in SolidWorks (3D CAD), AutoCAD (2D Drafting), Model-Based Definition (MBD), GD&T (ASME Y14.5), Tolerance Stack-up Analysis, Value Engineering, and Prototype Development.
- Experience with engineering methodologies such as DFMA, DFMEA, and DOE Fundamentals. Working knowledge of simulation tools is preferred.
- Basic metrology skills for manufacturing support and design validation.
- Experience preparing engineering risk management documents including Hazard Analysis, FMEA, and Fault Tree Analysis (FTA).
- Knowledge of ECN/ECR processes, NC/CAPA processes, technical report writing, and engineering documentation.
Preferred Qualifications
- Bachelor's or Master's degree in Mechanical Engineering or a related discipline.
- Experience in ophthalmic or medical device manufacturing is highly desirable.
- Exposure to regulated product development environments and global compliance requirements will be an added advantage.
Skills
FDARisk ManagementAutoCADSolidWorksPrototypingCompliance