Mechanical Verification Engineer
3 weeks ago
Job Description Role: Mechanical Verification Engineer Location: Mysore / Bangalore Experience Required: 25 Years Role Overview We are seeking a skilled Mechanical Verification Engineer to join our Autotransfusion System development team. The ideal candidate will have a strong mechanical engineering background with hands-on experience in verification and validation of medical devices, focusing on mechanical integrity, fitment, and environmental testing. This role involves verifying mechanical subsystems, assessing product reliability under IEC 60601-1 requirements, and conducting package, vibration, and environmental durability tests. Key Responsibilities: - Perform mechanical subsystem and system-level verification testing for Autotransfusion systems as per design inputs and regulatory standards (IEC 60601-1, ISO 14971, ISO 10993). - Conduct mechanical fitment, alignment, and tolerance verification using precision tools like vernier calipers, micrometers, and height gauges. - Execute mechanical endurance and fatigue tests to ensure design robustness and long-term reliability. - Perform vibration, drop, and packaging tests as per IEC 60601-1 and ISTA guidelines to validate product durability and transportation readiness. - Collaborate with design and manufacturing engineers to resolve non-conformances and ensure proper design verification coverage. - Develop test protocols, set up test fixtures, and document verification results in alignment with design control and quality processes. - Assist in environmental testing including temperature, humidity, and stress conditions to validate performance stability. - Contribute to design reviews, risk analysis, and verification planning documentation. - Support regulatory submissions and technical documentation with complete verification data and traceability. Required Qualifications: - Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering (with mechanical focus), or a related field. - 25 years of experience in mechanical testing and verification for medical or electromechanical systems. - Proficiency in using mechanical measurement tools such as vernier calipers, micrometers, dial gauges, and torque tools. - Knowledge of IEC 60601-1, IEC 60601-1-11, ISO 10993, and other relevant mechanical and safety standards. - Hands-on experience in vibration, packaging, and environmental test execution. - Familiarity with mechanical CAD tools (e.g., SolidWorks, Creo) and understanding of GD&T principles. Preferred Skills: - Experience with medical device enclosures, fluid path components, or mechanical assemblies. - Knowledge of test automation or data acquisition systems for mechanical verification. - Experience with mechanical fixture design and fabrication. - Strong documentation and analytical skills to evaluate mechanical test outcomes.
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