Business Unit: Ultrasound
Requisition Number: 242021
Primary Location: United States-Washington-Issaquah
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as a Global Risk Manager
This is a role
well suited to an ambitious professional, looking for the next step in their
career. As a Global Risk
Manager, you will be
- You will be positioned as a Risk Management expert within the Organization, who would be responsible to develop and oversee the execution of the global medical device risk management strategy for Siemens Ultrasound products in order to achieve products of high quality and maintain compliance to medical device risk management standards and regulations.
- Your quality background and expertise in ISO 14971 will be utilized to strengthen the Organizational understanding and importance of applying proper Risk Management processes and techniques during product development cycles, including the post-market phase.
- You will provide quality oversight to project teams in terms of the Risk Management System and corporate processes, including post-market information of similar products’ feedback into the new product development cycle.
- Your knowledge will be utilized to develop and maintain Post-Market Health Risk Evaluations across all products.
This position may suit you best if you relate with what is below, and
would like to develop your career with Healthineers
You are a motivated individual who strives for excellence and inspires others. You always want to do better.
- One of your strongest attributes is influencing other individuals for whom you would not have a direct reporting relationship.
- You are a detail oriented, logical thinker who is well organized and can manage multiple projects simultaneously.
- A proficiency for using new technologies to improve efficiencies within the organization is an interest of yours.
- You believe that sharing knowledge strengthens the Organization and leads to better outcomes.
- Willing to travel up to 10%, including internationally
Required skills to have for the success of this role
- 10+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry
- Extensive experience applying ISO 14971 standard
- Must be able to demonstrate significant knowledge and understanding of a Quality Management System and Regulatory processes and proficiencies. Ideal candidate will have a detailed working knowledge of 21 CFR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards. Training or certification of a quality auditor, risk management and/or quality engineer is highly desirable
- Strong understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods.
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific position before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.