Principal Engineer - Lead System Designer & Product Security Represent

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.
• Strong 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.