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 Systems
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Systems Engineer, you will be responsible for:
- You will be responsible for the Leading medical device Risk Hazard Assessments for Siemens Ultrasound product development projects, in order to achieve products of high quality and maintain compliance to medical device risk management standards and regulations.
- Your background and expertise in ISO 14971/24971 will be utilized to strengthen the organizational understanding and importance of applying proper Risk Management processes and techniques during product lifecycles, including the post-market phase.
- You will work with a variety of cross-functional project, engineering, and feature teams to ensure that they understand risk management, risk mitigations and verification, as well as assist the teams in technical, process, and compliance reviews. You will work closely with the lead project Systems Engineers to drive scope and requirements, and review verification results of risk control measures to confirm measures are appropriate.
- You will work with the Quality and Regulatory organizations to evaluate impact to existing and future products based on standards and regulations, including new standards.
- You will work with Quality Assurance to improve the Global Risk Management process and provide input into the selection and configuration of risk management and requirements tools such as Office, Polarion, Microsoft TFS, and Team Center.
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.
- A proficiency for using new technologies to improve efficiencies within the organization is an interest of yours.
- A desire to develop products that help and improve the clinical outcomes of patients
- One of your strongest attributes is influencing other individuals for whom you would not have a direct reporting relationship.
- You believe that sharing knowledge strengthens the Organization and leads to better outcomes.
- Willing to travel up to 5%, including internationally
- Bachelors, Masters, or Doctorate in Physics, Engineering, Systems Engineering or related field
- 5+ years experience in Systems Engineering, Design Engineering, Ultrasound Engineering, or related experience in a regulated industry. Ideal candidate will have experience in medical devices, preferably medical imaging and ultrasound.
- Strong understanding of risk management, requirements management, methodologies, and processes, including use of a variety of accepted methods.
- Experience applying ISO 14971/24971 standards to a complex product. Must be able to demonstrate 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.
- Can contribute to risk management as related to human factors and usability, software development, and DFMEA.
- Can participate in quality process improvements, complaints investigations, change control, and safety assessments.
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.
Job ID: 188814
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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