Siemens Healthineers · 2 months ago
Systems Engineer, Risk Management
YOW B
Full-time
Hybrid
Senior Level
$93K/yr - $143K/yr
5+ years expSiemens Healthineers is a leader in medical technology, dedicated to pioneering breakthroughs in healthcare. The Systems Engineer, Risk Management will ensure product risk management is performed according to relevant regulations and quality system procedures throughout the product lifecycle, collaborating with cross-functional teams to identify and mitigate risks.
Health CareHealth DiagnosticsMedicalMedical Device
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
Qualification
Required
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
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
Benefits
Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay.
Company
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
H1B Sponsorship
Siemens Healthineers has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
Anton Ebert
Technology Focus Topic Lead - Digital Twinning
Recent News
2026-01-21
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