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.
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.
Remidio Bengaluru, Karnataka, IND Office
12 Rmp Apartment 1st Cross 1st Main Road, Bengaluru, Karnataka, India, 560057
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