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.