Systems Engineer, Risk Management

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.

Under the supervision of the Head of Requirements and Risk Management, the Systems Engineer, Risk Management will ensure product risk management is performed according to ISO14971, relevant regulations, and Siemens Healthineers Quality System Procedures throughout the product lifecycle.  

Responsibilities

• Leading subsystem and system-level risk analyses throughout the product lifecycle, ensuring compliance with ISO 14971, Siemens' Quality Management System, and regulations.

• Collaborating with cross-functional team members to identify hazards, evaluate and control risks, and monitor the implementation, verification, and effectiveness of risk control measures.

• Acting as Risk Management SME for xFMEA activities (supporting Usability, Manufacturing, and Development Engineering) on complex electro-mechanical, software-enabled, connected systems, guiding project teams on application of risk management principles and processes.

• Leading cross functional discussions to ensure that all product hazards are identified and mitigated effectively.

• Evaluating and documenting benefit-risk analyses and leading overall residual risk evaluation for new product development and continuous product support activities.

• Driving cross-functional risk evaluations and impact assessments for post-market design and manufacturing changes, deviations, and complaints using systems engineering principles.

• Leading periodic and event driven risk reviews of the Risk Management Files for commercialized products.  Contributing to Periodic Safety Update Reports (PSURs) and other post-market risk reports upon request.

• Supporting the medical safety teams with assessment and responses to regulatory agencies and competent authorities related to medical device reporting requirements.

• Supporting design reviews, audits, and inspections for risk-related matters, ensuring compliance with regulatory requirements and industry standards.

• Tracking and reporting progress to teams and stakeholders verbally and in writing.

• Communicating with other Risk Management team members to ensure harmonization of risk management strategies across projects, share lessons learned and ensure use of common tools and ideas within the team. Ensure consistency across system and subsystem levels.

• Supporting continuous improvement of the Risk Management Process by identifying new opportunities and assisting with the development or improvement of the organization's risk management policies, procedures, and tools.

Required Knowledge/Skills, Education, and Experience

• Bachelor's Degree or equivalent in Systems Engineering or related field

• 5+ years' experience in a systems engineering or risk management role supporting product development in a regulated medical device or life sciences industry. Experience with requirements, design inputs/outputs, and verification/validation.

• Experience driving system-level hazard and risk analyses across both new product development and sustaining engineering phases.

• Experience with Systems Engineering-driven processes and best practices for risk management.  Strong understanding of stakeholder requirements, design inputs/outputs, and hazardous situation analysis.

• Solid understanding of principles and application of ISO 14971 and TIR 24971.

• Familiarity with in vitro diagnostic device development processes including ISO13485, IEC 61010, IEC 62304, and IEC62366. 

• Strong leadership abilities with a focus on collaboration and teamwork.  Demonstrated ability to critically challenge team.

• Demonstrated ability to work independently as well as part of a cross functional product development team.

• Excellent collaboration and communication skills for facilitating risk-related discussions.

• Excellent technical writing, communication, and presentation skills (across all levels of the organization).

• Good attention to detail; aspiration for technical excellence.

• Strong organization and time management skills; experience tracking and reporting progress using data-driven dashboards.

• Proven track record of delivering quality results in a resource-constrained environment.

• Proficiency with Microsoft Office Suite.

Preferred Knowledge/Skills, Education, and Experience

• Working knowledge of IEC62304 and IEC60812 is preferred.

• Working knowledge of risk management tools such as Stature, DOORS, or similar is preferred.

• Familiarity with critical care or primary care assays is preferred.

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.

To find out more about Siemens Healthineers' businesses, please visit our company page at Siemens Healthineers Canada.

The base pay range for this position is:

Base pay offered may vary depending on job-related knowledge, skills, and experience. Siemens Healthineers  offers a variety of health and wellness benefits including paid time off and holiday pay.  

This information is provided per the required laws and regulations. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.

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