GE HealthCare Senior Lead System Designer 

United States, Wisconsin 

91295674

Duties include (but are not limited to)

• Provide Systems Design leadership for new product development programs as a key member of a cross functional team.

• Leads the engineering team in the implementation of the design process. This includes requirements management, risk management (including FMEA), DFX, verification & validation, compliance to internal processes & industry standards, and design transfer to production.

• Responsible for the user and system requirements that define the product.

• Partners closely with the quality organization to implement efficient and effective design processes.

• Ensures quality targets are satisfied and retires technical risks as they arise on the program or released product.

• Leading the design team in the development of verification and validation planning and execution for NPIs and released products

• Support manufacturing and the installed based through corrective and preventative actions to ensure customer satisfaction.

• Driving the architecture, test strategies, design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality.

• BS in a STEM field with 10+ years of relevant experience, or a Masters Degree with 8+ years of experience

• Significant product development experience. Including requirement definition through verification and validation.

• Experienced in risk management including FMEA.

• Strong understanding of engineering product development processes.

• Able to operate with moderate autonomy.

• 5+ years of medical device experience.

• 3+ years of lead system designer experience.

• Able to influence peers and cross functional partners.

• Experience with Medical device standards like IEC60601-1

• Experience with DFX (manufacturability, serviceability, reliability, test, etc)

• Self-starter, energizing, and results oriented.