Systems Engineer, Risk Management

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. Realizes the functional concept of systems in a project by technical detailed solutions. 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. The Base Pay Range For This Position Is Min $93,000 - Max $143,000 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. Equal Employment Opportunity Statement Siemens Healthineers is committed to creating a diverse environment and is proud to be an equal opportunity employer. While we appreciate all applications we receive, we advise that only candidates under consideration will be contacted. Accessibility Siemens Healthineers is committed to excellence in serving all employees and customers, including people with disabilities. Siemens Healthineers will strive to ensure that policies and procedures established with respect to the provisions of its goods and services to persons with disabilities are consistent with the principles of dignity, independence, integration and equal opportunity as provided in the Accessibilities for Ontarians with Disabilities Act, 2005. Siemens Healthineers will continue to attempt to meet the needs of all its customers, including but not limited to persons with disabilities, in an effective and timely manner. Data Privacy We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. By submitting personal information to Siemens Healthineers or its affiliates, service providers and agents, you consent to our collection, use and disclosure of such information for the purposes described in our Privacy Notice here. To all recruitment agencies Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. Beware of Job Scams Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site. Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Information Technology Industries: Hospitals and Health Care Referrals increase your chances of interviewing at Siemens Healthineers by 2x Get notified about new System Engineer jobs in Ottawa, Ontario, Canada . #J-18808-Ljbffr