Company:A Large Global Organization

Key Skills: ISO 13485, Vulnerability Management, Quality Management System, Threat Modeling, Medical Devices, Governance

Roles & Responsibilities:

- Lead system design and design assurance activities for medical device software and connected product architectures.
- Maintain alignment between product development processes, the Quality Management System and applicable medical device regulations.
- Drive cybersecurity activities including threat modeling, security risk assessment, vulnerability management and product security reviews.
- Ensure complete design controls, traceability, Design History File records, verification and validation evidence and regulatory documentation.
- Represent product security in technical and quality governance forums,



and provide guidance on secure development and compliance documentation.

Skills Required:

- 10-15 years of relevant experience in medical device software, software quality, design assurance, QMS or product security.
- Strong experience in QMS within a medical device company.
- Hands-on experience with ISO 13485 quality standards and compliance.
- Experience in vulnerability management and threat modelling.
- Solid knowledge of Design History File (DHF) and design control processes.

Good to Have:

- Experience in governance models for software quality, product security or regulatory compliance.

Education:

- Any graduation in any branch.

📌 Principal Engineer - Lead System Designer & Product Security Representative (Bengaluru)
🏢 MyCareernet
📍 Bengaluru