- You will be responsible for leading the execution of the Systems Engineering process for Siemens Ultrasound product development projects, in order to achieve products of high quality and maintain compliance to medical device standards and regulations.
- You will work with a variety of cross-functional project, engineering, and feature teams to proactively lead them through requirements definition, system design, risk hazard assessment, system integration, and technical specifications as well as to define and review the features with stakeholders.
- You will collaborate with project management, product management, clinicians, UX designers, quality engineers, customers, SAFe solution engineers, and implementation engineers to create feature concepts, explain system functions, and lead features and clinical solutions to a successful release.
- Your engineering background will be utilized to define System and Subsystem Requirements, as derived from clinical and product requirements, and use them to derive module and component requirements. You will work with the System Verification Team on protocols to verify the requirements and create traceability matrices while working effectively throughout the project to drive efficiency improvements.
- You will lead integration efforts by developing and executing integration plans across projects and features at both the system and subsystem levels.
- Your background and expertise in ISO 14971/24971 will be utilized to apply proper Risk Management processes and techniques during product lifecycles, including the post-market phase.
- You are a motivated individual who strives for excellence and inspires others. You always want to do better.
- You are driven by a desire to develop products that help and improve the clinical outcomes of patients.
- You appreciate autonomy and want to be part of a culture of accountability, transparency, and cross-functional teamwork.
- A proficiency for using new technologies to improve efficiencies within the organization is an interest of yours.
- One of your strongest attributes is positively 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.
- You are willing to travel up to 5%, including internationally.
- Bachelors, Masters, or Doctorate in Physics, Engineering, Systems Engineering or related field.
- 8+ years experience required (10+ desired) in Systems Engineering, Electrical Engineering, Mechanical Engineering, Ultrasound Engineering, Software Engineering, Biomedical Engineering, Biophysics, or related experience in a regulated industry.
- Ideal candidate will have experience in medical devices, preferably medical imaging and ultrasound.
- Understanding of the practical application of Systems Engineering and Design Controls in Medical Device product development, including integration.
- Strong understanding of requirements management, methodologies, and processes, including use of a variety of accepted methods.
- Can lead and contribute to product risk hazard management as related to human factors and usability, software development, and DFMEA.
- 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.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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