Job description
Key Responsibilities: Develop and maintain mechanical components, assemblies, and associated engineering documentation. Drive localization initiatives by identifying and qualifying alternate materials, components, and suppliers. Evaluate and recommend Indian-equivalent alternatives to European-standard components while ensuring functional and regulatory compliance. Collaborate with design teams to adapt products to local standards, material availability, and supply chain requirements. Support product complaint investigations and prepare required technical documentation and reports. Initiate, review, and implement engineering changes through Engineering Change Request (ECR) and Engineering Change Order (ECO) processes. Ensure compliance with applicable medical device regulations and standards, including IEC 60601 and related safety requirements. Participate in cross-functional discussions involving engineering, procurement, quality, manufacturing, regulatory, and supplier teams. Coordinate with global engineering teams to resolve technical issues, align design modifications, and support product lifecycle management activities. Support design verification and validation (V&V) activities for engineering changes, product enhancements, and localization projects. Contribute to product reliability improvement initiatives through failure analysis, FMEA, root cause investigations, and design reviews. Ensure engineering documentation, change management activities, and complaint handling records comply with applicable quality management systems and regulatory requirements. Qualifications & Required Skills: Bachelor's degree (B.E./B.Tech.) in Mechanical Engineering. 4–10 years of experience in the medical device, healthcare equipment, or other highly regulated industries. Strong technical expertise in mechanical design, component development, engineering calculations, testing methodologies, and mechanical system analysis. Solid understanding of manufacturing processes such as machining, sheet metal fabrication, casting, molding, welding, and assembly. Experience in supplier qualification, localization projects, and component validation. Good knowledge of international standards and regulatory requirements, such as IEC 60601, Machinery Directive 2006/42/EC, IEC 60721-3-2, ISTA, ASTM, and related standards. Familiarity with engineering change management processes and product lifecycle management practices. Strong analytical, problem-solving, and troubleshooting skills. Effective communication and collaboration skills with the ability to work in cross-functional and global teams.
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