Lead System Designer Install Base LSD
Job Summary
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 nonhazardous investigations CAPA nonconformance management and compliance activities for Xray products working closely with Engineering Risk Management Quality Manufacturing and other crossfunctional teams.
- Own postproduction engineering activities including customer complaint analysis periodic risk assessments and driving continuous improvement initiatives.
- Drive design optimization and tradeoff 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 Xray product lifecycle.
- Ensure sustained compliance with global quality and regulatory requirements.
Required Qualifications
- Bachelors 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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
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Additional Information
Relocation Assistance Provided: Yes
Required Experience:
IC
About Company
GE HealthCare provides digital infrastructure, data analytics & decision support tools helps in diagnosis, treatment and monitoring of patients