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

Adecco India; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Adecco India seeks a skilled professional to drive end-to-end product technical success through system architecture, requirements, risk analysis, and cross-functional integration across hardware, software, and firmware.

The role focuses on regulatory compliance by managing documentation, verification/validation, usability engineering, and audits with R&D, design, quality, and regulatory teams involved in post-market activities and external testing.

Qualifications

• Knowledge of medical device quality and safety standards and regulations (ISO 60601-x)
• Experience with requirements specification and traceability
• Experience creating and maintaining Design History File (DHF), System Requirements Specification (SyRS), Risk Management File (RMF), and Usability Engineering File
• Familiarity with product life-cycle management

Responsibilities

• Drive end-to-end product technical success through system architecture design, requirements development, risk analysis, and cross-functional integration across hardware, software, and firmware
• Ensure regulatory compliance by managing documentation, verification and validation, usability engineering, and audits
• Collaborate with R&D, design, quality, and regulatory teams supporting audits, post-market activities, and external testing

Skills

Regulatory knowledge

Regulatory standards

Documentation experience

Requirements traceability

DHF SyRS RMF Usability

Life-cycle management

Risk management (ISO 14971)

FDA/EU regulations

Cross-functional collaboration

Job description

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