Medical Device Risk Manager

Siemens Healthineers; Pune District; On-site; INR 1,500,000 - 2,800,000; Full time

Job summary

Siemens Healthineers seeks a seasoned professional to lead risk management for digital oncology information system software, including EMR/EHR components. You will develop and maintain Risk Management Files, collaborate with software teams, and ensure compliance with international standards to safeguard patient safety.

The role requires expertise in medical device risk analysis, regulatory awareness, and strong English communication.

Qualifications

• Bachelor’s degree in Healthcare, Science or Engineering with several years of related experience.
• At least 3 years of relevant experience in medical device risk management or digital electronic health record systems.
• At least 3 years of relevant experience in Healthcare Software Development.
• Knowledge in ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304 and IEC/TR 80002-1.
• Medical Device Risk analysis, risk control measure evaluation and validation testing experience.
• Good written and verbal communication in English language.

Responsibilities

• Develops and maintains clinical software Risk Management Files including risk management plans, hazard analyses and risk assessments.
• Collaborates with healthcare software development teams to implement risk controls in clinical software per ISO 14971.
• Supports regulatory inspections and notified body audits as risk management expert.
• Keeps abreast of changes to regulations and standards affecting risk management processes.

Skills

English communication

Regulatory awareness

Risk management

Cross-functional collaboration

Education

Bachelor’s degree in Healthcare/Science/Engineering

Tools

Outlook

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Ensure the quality of software implementation and the safety, performance and reliability of integrated software and hardware by active participation in architecture, design and code reviews, unit testing, software debugging, system troubleshooting and overall resolution.

You will be part of the Global Risk Management Team, developing medical device risk management program and ensuring compliance with international medical device standards. You will provide guidance and support to enable cross-functional teams to develop and maintain risk management files for medical device software, with primary responsibility for the Digital Oncology Information System (OIS) software portfolio which includes Electronic Medical Record (EMR) and Electronic Health Record (EHR). This role is key to patient safety.

Summary

• 5 Years of experience in Leads Risk Management efforts, processes and process improvements for the software Product portfolio, with a main focus on Digital Oncology Information system (OIS) software products.
• Develops and maintains clinical software Risk Management Files that include risk management plans, hazard analyses, risk assessments and post market surveillance.
• Collaborates as risk management file owner with healthcare software development teams to ensure the comprehensive implementation of risk control measures in the clinical software in accordance with risk management procedure and international standard ISO 14971
• Keeps abreast of changes to regulations and applicable standards as they bear on risk management process and risk management file
• Participates in regulatory inspection and notified body audits as risk management subject matter expert.
• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams.

Minimum Required Skills And Knowledge

• Bachelor’s degree in Healthcare, Science or Engineering with several years of related experience
• At least 3 years of relevant experience in medical device risk management or digital electronic health record system
• At least 3 years of relevant experience in Healthcare Software Development
• Knowledge in ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304 and IEC/TR 80002-1
• Medical Device Risk analysis, risk control measure evaluation, implementation and validation testing experience
• Good written and verbal communication in English language
• Strong interpersonal skills
• Knowledge and understanding of international safety standards for medical devices
• Related experience with US Class II or III (EU class IIb or III) medical devices is highly desired
• Related experience with Software as a Medical Device (SaMD), Risk analysis and Cybersecurity Risk management
• Proficient in utilizing business tools such as: Outlook, Microsoft Word, Excel, and PowerPoint.

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

As an equal opportunity employer, we welcome applications from individuals with disabilities.