Job Summary for LSD
As a Lead Systems Designer in Imaging Platform team, you’ll be responsible for to deliver technical content , performance, intellectual property and quality deliverables of an NPI program or Platform solutions for GE Healthcare Products. The position has design responsibility to include ensuring: feature and functionality, quality, reliability, serviceability, manufacture-ability, regulatory, compliance and cost.
Additionally, the LSD translates user needs into system requirements and leads the architectural decomposition and allocation to subsystems.
As a Lead Systems Designer within the Imaging Platform team, responsible for delivering high-quality, compliant, and scalable platform solutions for GE HealthCare products. This role owns end-to-end system design accountability, ensuring alignment with performance, quality, reliability, serviceability, manufacturability, regulatory, and cost objectives across NPI programs and platform releases.
The position involves translating user and business needs into well-defined system requirements, leading architectural design, and driving decomposition and allocation of requirements to subsystems. Additionally, ensures strong traceability, adherence to QMS processes, and integration of cybersecurity and compliance requirements throughout the development lifecycle.
Acts as a key technical leader, collaborating across cross-functional teams to ensure robust design, effective verification strategies, and successful release delivery.
Job Description
Essential Responsibilities:
- Ensuring that the quality targets are satisfied and retires technical risks as they arise on the program
- Leading the design team and design control process from requirements development and design planning to design transfer
- Leading the design team in the development of verification and validation planning and execution
- 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
- Apply principles of SDLC, CI, Software and Product Security, Scalability, Documentation Practices, refactoring and Testing Techniques in alignment of Healthcare domain
- Driving the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality
- 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
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones
- Lead continuous improvement activities by driving the implementation of process and product quality and improvement initiatives
- Ensure performance and security parameters are adhered by the development team
Qualifications and experience
- Bachelor’s Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math)
- Master’s Degree in Computer Science/Math or related field
- A minimum of 11 to 18 years of professional experience (include technical skill)
LSD is a Systems Engineer / Systems Architect, not a Software Solution Architect or a Technical Project Manager. Top 3 competencies:
- The NPI Experience: Proven experience taking a medical device or healthcare platform from concept to launch.
- Regulated QMS Mastery: Familiarity with medical device standards. They should live and breathe ISO 13485 and FDA design controls.
- Risk & Compliance Ownership: Experience leading ISO 14971 risk management (FMEA/FTA) and ensuring cybersecurity / product security parameters are met.
- Must-have: "Systems Engineer" OR "Systems Designer" OR "Systems Architect" OR "Lead Systems Engineer"
- Domain: "Medical Device" OR "MedTech" OR "Healthcare Imaging" OR "Product Development Lifecycle"
- Standards/process: "ISO 13485" OR "IEC 62304" OR "ISO 14971" OR "Design Controls" OR "FMEA" OR "Traceability" OR "DOORS" OR "Jama"
- Nice-to-have: Experience in managing IoT/Data Platforms/Imaging Integration
