Siemens

Project Quality Engineer- Cybersecurity Process Specialist

Siemens  •  Bengaluru, IN (Onsite)  •  1 day ago
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Job Description


Job ID

517436

Posted since

10-Aug-2026

Organization

Siemens Healthineers

Field of work

Quality Management

Company

Siemens Healthcare Private Limited

Experience level

Experienced Professional

Job type

Full-time

Work mode

Office/Site only

Employment type

Permanent

Location(s)

  • Bangalore - Karnataka - India

SHS AT QT (Advanced Therapies Quality & Regulatory Team) is a global organization focused on ensuring product quality, regulatory compliance, and patient safety across the product lifecycle. It supports innovation by integrating Quality Engineering, Risk Management, Reliability Engineering, and regulatory expertise into product development. The team drives digitalization, AI adoption, and continuous process improvement to enhance efficiency and compliance. SHS AT QT aims to deliver high-quality healthcare solutions faster, enabling better outcomes for patients, customers, and healthcare providers worldwide.

Responsibilities
  • Analyzing, collecting data, and providing accurate, documented information about the status of quality
  • Verifying the correctness of quality related development results in compliance with the Quality Management Plan & authorize their release for medical devices
  • Validation of compliance to basic requirements, e.g. ISO standards and regulations like Medical Device Regulation (European Union Regulation), Quality system regulation (US FDA)
  • Assessment of completeness of Design history file and Device master records?- Participate in reviews as per QMS, external and internal audits
  • Apply technical understanding of cybersecurity concepts to support project teams.
  • Identify gaps in existing cybersecurity processes and drive improvements.
  • Verify that cybersecurity deliverables are complete and compliant for product launches, regulatory submissions, audits, and technical file updates
Experienced in:
  • Product risk management & non-product software validation processes for medical devices
  • Creation and maintenance of technical file/summary technical documentation (STED)
  • Medical device development (including SW) and Software engineering best practices
  • Agile methods / TIR45
  • Experienced in end-to-end (E2E) cybersecurity process handling across the product lifecycle
  • Reviews and interprets cybersecurity findings raised by various regulatory bodies and supports the related remediation activities
  • Supports the maintenance of post-market cybersecurity documentation to keep products audit-ready and prepared for regulatory review
Knowledge
  • Implementing ISO 9001, 13485, ISO 14971, IEC 62304 & IEC 82304 within projects
  • Compliance of requirements from MDR, QSR
  • Non-regulated software like Apps for Apple / Android
  • Cybersecurity (ISO 80001, SW Vulnerability Management), Information security (ISO 27001)
  • Strong knowledge of product cybersecurity processes and good technical understanding of healthcare/medical device cybersecurity requirements
  • Knowledge of cybersecurity expectations from various regulatory bodies (FDA,EU & Korea etc), including FDA premarket & postmarket cybersecurity guidance,
  • Knowledge of EU MDR requirements (MDCG 2019-16, Annex I security-related essential requirements), IEC 81001-5-1 (health software security), and IMDRF cybersecurity principles — at a process/regulatory-expectation level

Siemens

About Siemens

Siemens AG (Berlin and Munich) is a leading technology company focused on industry, infrastructure, mobility, and healthcare. The company’s purpose is to create technology to transform the everyday, for everyone. By combining the real and the digital worlds, Siemens empowers customers to accelerate their digital and sustainability transformations, making factories more efficient, cities more livable, and transportation more sustainable. A leader in industrial AI, Siemens leverages its deep domain know-how to apply AI – including generative AI – to real-world applications, making AI accessible and impactful for customers across diverse industries. Siemens also owns a majority stake in the publicly listed company Siemens Healthineers, a leading global medical technology provider pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. In fiscal 2025, which ended on September 30, 2025, the Siemens Group generated revenue of €78.9 billion and net income of €10.4 billion. As of September 30, 2025, the company employed around 318,000 people worldwide on the basis of continuing operations.

Industry
Manufacturing & Production
Company Size
10,000+ employees
Headquarters
Munich, DE
Year Founded
Unknown
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