Engineer II, Systems || Medical Device || Bangalore (Work From Office

Drives end-to-end product technical success through system architecture design, requirements development, risk analysis, and integration across hardware, software, and firmware. Ensures regulatory compliance by managing documentation, verification and validation, usability engineering, and cross-functional collaboration with R&D, design, quality, and regulatory teams supporting audits, post-market activities, and external testing aligned with medical device standards

Role & responsibilities

• Knowledge of medical device technology, applicable quality and safety standards, and regulations (ISO 60601-x)
• Demonstrated ability to deal with a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting assignments
• Strong analytical, problem-solving, and interpersonal communication skills
• Familiarity with engineering change control processes and change impact assessment
• Demonstrated initiative, attention to detail, customer focus, and commitment to ongoing process improvement
• Experience with requirements specification and traceability
• Experience in creating and maintaining Design History File (DHF) elements including System Requirements Specification (SyRS), Risk Management File (RMF), and Usability Engineering File
• Knowledge of product life-cycle management
• Experience with project management a plus
• Experience with documentation of design/development activities
• Understanding of medical devices and human respiration system
• Experience in risk management and ISO 14971 is added advantage
• Knowledge of FDA regulations and Medical Devices Directive 93/42/EEC
• GDP & GMP Experiences (Good Documentation Practice & Good Manufacturing practice