Mechanical Design Engineer (Medical Devices)

Role & responsibilities

• Design and develop medical device mechanical components and assemblies from concept to production
• Take full ownership of assigned projects, ensuring on-time completion with minimal supervision
• Create detailed 3D CAD models, engineering drawings, and specifications with appropriate GD&T
• Select appropriate materials, components, and manufacturing processes for medical devices
• Perform engineering analyses including tolerance stack-ups, stress analysis, and failure mode investigations
• Collaborate with cross-functional teams including electronics, firmware, and regulatory affairs
• Design for manufacturability, reliability, and cost-effectiveness
• Develop and execute verification and validation testing protocols
• Participate in risk management activities including FMEA and hazard analyses
• Identify and qualify vendors for components and manufacturing processes
• Prepare technical documentation for regulatory submissions (Indian and future FDA)
• Continuously improve existing designs based on feedback and performance data

Preferred candidate profile

• Bachelor's or Master's degree in Mechanical Engineering or related field
• 3+ years of experience in mechanical design for medical devices or similar regulated products
• Proficiency in 3D CAD software (preferably SolidWorks)
• Strong knowledge of manufacturing processes, material selection, and DFM principles
• Experience with GD&T and engineering tolerancing
• Familiarity with medical device standards and regulations (ISO 13485, IEC 60601, FDA QSR)
• Understanding of sterilization methods and biocompatibility considerations for medical devices
• Experience with prototype development, testing, and validation
• Knowledge of risk management processes (ISO 14971) and quality management systems
• Strong problem-solving abilities and attention to detail
• Self-motivated with exceptional initiative and ability to work with minimal supervision
• Excellent communication skills and ability to work in a collaborative environment
• Experience bringing a medical device from concept to production is highly desirable

Startup Environment and Mindset: