Lead System Designer for Product Lifecycle and Compliance

Lead System Designer - Install Base LSD

Job Description Summary

The Lead System Designer for install base is a cross functional engineering role that applies a structured approach, systems thinking mindset, and disciplined processes to balance both customer needs and business objectives. As the Lead System Designer for Install Base products, this position owns end to end responsibility for ensuring compliance, safety, regulatory requirements, customer satisfaction, across the entire product lifecycle. The role requires close collaboration with engineering, quality, regulatory, and cross functional teams to drive robust, compliant, and sustainable solutions.

Job Description

Roles and Responsibilities

• Lead hazardous and non‑hazardous investigations, CAPA, non‑conformance management, and compliance activities for X‑ray products, working closely with Engineering, Risk Management, Quality, Manufacturing, and other cross‑functional teams.
• Own post‑production engineering activities, including customer complaint analysis, periodic risk assessments, and driving continuous improvement initiatives.
• Drive design optimization and trade‑off decisions, considering performance, cost, security, latency, and scalability.
• Support and lead regulatory submissions, inspections, and audits as the engineering representative.
• Ensure design outputs comply with verification and validation (V&V) requirements, supported by complete and objective evidence.
• Be accountable for the delivery, accuracy, and quality of technical documentation and Quality Management System (QMS) deliverables.
• Oversee design changes and sustaining engineering activities, ensuring all changes meet quality, safety, and regulatory requirements.
• Provide technical oversight and guidance for field and manufacturing issue resolution, including root cause analysis, risk assessment, and execution of appropriate CAPA actions.
• Maintain, govern, and ensure completeness of Design History Files (DHF) and associated technical documentation throughout the X‑ray product lifecycle.
• Ensure sustained compliance with global quality and regulatory requirements.

Required Qualifications

• Bachelor’s degree in Engineering.
• Broad exposure to hardware, software, and systems design, with technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, Systems, etc.).
• minimum 2+ years of experience working in system and/or managing lifecycle for products.
• Strong knowledge and experience in healthcare regulatory and safety requirements
• Healthcare domain experience

Desired Characteristics

• Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skill.

Inclusion and Diversity

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information

Relocation Assistance Provided: Yes

Experience Level

Senior Level