The Role
Design and develop Class I and II medical devices from concept through commercialization. Responsibilities include CAD modeling, manufacturing drawings, DFMEA, risk assessment, DFM/DFA, prototyping, verification and validation testing, BOMs, engineering documentation, ECN/ECR management, quality issue resolution, and manufacturing support. The role collaborates with industrial design, electronics, manufacturing, quality, and regulatory teams while ensuring compliance with medical device standards.
Summary Generated by Built In
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 Required
- 7+ years of experience in mechanical design engineering
- Experience designing and developing Class I and Class II medical devices
- End-to-end electro-mechanical product development experience from concept through commercial release
- Proficiency in SolidWorks 3D CAD
- Proficiency in AutoCAD 2D drafting
- Experience with Model-Based Definition, GD&T, ASME Y14.5, tolerance stack-up analysis, value engineering, and prototype development
- Understanding of ISO 13485, FDA regulations, and applicable medical device regulatory standards
- Experience with medical-grade metals, plastics, polymers, and associated manufacturing processes
- Experience with DFMA, DFMEA, and DOE fundamentals
- Experience preparing engineering risk management documents, including hazard analysis, FMEA, and Fault Tree Analysis
- Experience with ECN/ECR, NC/CAPA, technical report writing, and engineering documentation
- Basic metrology skills for manufacturing support and design validation
- Bachelor’s or Master’s degree in Mechanical Engineering or a related discipline
- Experience in ophthalmic or medical device manufacturing
- Knowledge of ISO 15004-1 and ISO 15004-2
- Working knowledge of simulation tools
- Exposure to regulated product development environments and global compliance requirements
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The Company
What We Do
Remidio is an innovative ISO 13485 certified medical device company that seeks to create Healthcare Access by combining the simplicity of product design with cutting edge technology and sustainable business model innovations. Remidio uses principles of Design Thinking and involves key stakeholders during the product development process – clinicians, patients, and health workers, with a view to designing product solutions that are simple to use, clinically relevant, reliable, and scalable. Remidio’s CE marked and FDA 510k registered retinal imaging devices have helped screen and impact more than 7.5 million patients in 15 countries globally, as a result of increased access provided by the ease of use and affordability of Remidio’s patented optics on the smartphone platform.
