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Systems Design Engineer

Job Description Summary

The Systems Design Engineer role has the responsibility to deliver the design of features. Activities include early design concepts and prototyping, requirements development, traceability and flow down, architecture / system design and analysis, FMEA generation, development of Verification and Validation test procedures, and support to manufacturing and field issues.

 

Duties include (but are not limited to):

  • Providing domain expertise to serve as the main integrator between the hardware and software functions to deliver the best high-quality product.
  • Create workflows, early design concepts, and design approach to drive the definition and design of reusable platform capabilities, features, and experiences.
  • Working across functions and team boundaries to define, design, and implement the next generation of products.
  • Leverage qualitative research methods to understand user needs, use cases, and design solutions.
  • Identify the risks and impact of technical solutions on user experiences and create a UX plan to ensure the user needs and risks are accounted for.
  • Working with customers, Product Management, Marketing and field personnel to refine requirements which can be refined by the engineering teams.
  • Delivering and incorporating feedback results into new hardware, software, and service specifications
  • Ensure the products design is safe and fulfills the intended user needs.
  • This design should include CTQs such as regulatory compliance, risk assessment, reliability, serviceability and manufacturability.

 

Quality Specific Goals:

Aware of and comply with the GE HealthCare Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. Complete all planned Quality & Compliance training within the defined deadlines. Identify and report any safety, reliability, quality, or compliance concerns and take immediate corrective action as required. Maintaining regulatory compliance and other legal requirements Knowledge and understanding of GE HealthCare Design Controls Procedures and operates within them in managing programs that control the design of the device in order to ensure that specified design requirements are met (adjust for band level of role) Knowledge in FDA design control standards or requirements.

 

Qualifications:

Bachelor’s degree in engineering or STEM discipline. 1 year Product development experience in Engineering. Proven ability to develop timely and effective solutions for challenging design problems. Able to leverage research and data to support design recommendations. Solid communication skills with an ability to collaborate compassionately and inclusively with cross-functional teams. Ensure compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables

 

 

Preferred Qualifications:

Masters degree in a STEM discipline Self-starter, energizing, results oriented, and able to multi-task. Demonstrated problem solving ability and results orientation.