Principal Engineer - Lead System Designer & Product Security Representative_104801

MyCareernet; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

MyCareernet in Bengaluru is seeking an experienced professional to lead system design and design assurance for medical device software and connected product architectures.

You will ensure alignment between product development processes, the Quality Management System, and applicable medical device regulations, while driving cybersecurity activities including threat modeling, vulnerability management, and product security reviews.

Qualifications

• 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.

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

ISO 13485

Vulnerability Management

Quality Management System

Threat Modeling

Medical Devices

Governance

Job description

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

• 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.