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Open nowPosted 32 days ago

Senior Mechanical Design Engineer

Remidio10 open roles

Where
Bengaluru
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Your applicationOpen nowSenior Mechanical Design EngineerRemidio · Bengaluru

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Share of postings closed within
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  3. 12.1%7 days
  4. 19.1%14 days
  5. 35.6%30 days
  6. 52.7%60 days
This job: posted 32 days ago

The posting

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.
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