Senior Mechanical Design Engineer

REMIDIO INNOVATIVE SOLUTIONS; Bengaluru; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Remidio Innovative Solutions is seeking an experienced Mechanical Design Engineer with 7+ years of experience in Class I & II medical devices. You will drive end-to-end design from concept to commercialization, applying CAD tools, MBD, GD&T, and DFMEA to deliver robust electro-mechanical products.

The role requires hands-on development across the full product lifecycle, adherence to ISO 13485 and FDA standards, and collaboration with Quality and Regulatory teams to ensure compliant,

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering or related field.
• 7+ years of design and development experience in Class I/II medical devices is required.
• Experience in regulated product development and global compliance is highly desirable.

Responsibilities

• Support the design and development of new medical devices based on customer requirements and CTQ parameters.
• Design mechanical systems and components using CAD while adhering to standards.
• Develop design solutions through analysis, evaluation and problem solving.
• Create detailed 2D drawings and manage ECN/ECR processes.
• Participate in DFMEA and product risk assessment activities.
• Collaborate with cross-functional teams including Industrial Design, Electronics, Manufacturing, Quality, and Regulatory.
• Design for Manufacturing and Design for Assembly principles; develop jigs, fixtures, and packaging.
• Support verification activities including shock, vibration, reliability and IEC testing.

Tools

SolidWorks

AutoCAD

Model-Based Definition

GD&T

Tolerance Stack-up Analysis

Prototype Development

DFMA

DFMEA

DOE Fundamentals

Job description

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.
• 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.