About Us: GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary: Position is responsible for providing process engineering leadership to various systems. In addition, this position is accountable for achieving quality objectives, meeting development schedules, communicating program status, leading technical risk retirement, and escalating issues when appropriate to facilitate transparency.
Essential Responsibilities: 1. Working on a team responsible for new product development 2. Working closely with cross-functional groups in delivering effective new product development process results 3. Leading technical risk retirement across subsystems 4. Handling cross-functional program activities. 5. Ensuring compliance with Design History File (DHF) and other QMS requirements 6. Managing quality objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives 7. Ensuring that quality targets are met and technical risks are retired 8. Leading the design team and design control process from requirements development and design planning to design transfer 9. Leading the design team in the development of verification and validation planning and execution 10. Developing requirements flow down, architecture/system design and analysis, risk analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction 11. Driving the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality
Quality-Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones 5. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Qualifications/Requirements: 1. Master's / Bachelor's Degree in Electrical or Biomedical Engineering or equivalent 2. atleast 5 years experience in design and development of medical equipment technologies 2. Demonstrated ability to work in a cross-functional project team and to drive project design plans to completion 3. Strong understanding of the GEHC Quality Management System 4. Familiarity with ISO, FDA and other regulatory standards
Desired Characteristics: 1. Strong verbal and written communication skills 2. Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues 3. Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program 4. Strong interpersonal skills 5. Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program 6. Familiarity with clinical workflows
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