Join GE HealthCare as an Architect in Product Safety & Regulatory Engineering, shaping the future of X-Ray Tube and X-Ray Generator portfolios. This pivotal role involves leading product safety, regulatory compliance, and risk management throughout the product lifecycle.

You will ensure our innovative medical imaging solutions meet global safety and quality standards, supporting everything from new product development to lifecycle engineering initiatives. Partner with diverse, global teams to drive compliant product development and achieve necessary regulatory approvals.

GE HealthCare is dedicated to creating a world where healthcare has no limits. We empower our employees to turn groundbreaking ideas into reality, fostering an environment where every contribution builds a healthier world.

Provide expert technical leadership in Product Safety, Regulatory Compliance, Risk Management, and Design Controls for X-Ray Tubes and X-Ray Generators.

Assess the impact of engineering and manufacturing changes on global regulatory and safety compliance.

Lead comprehensive product risk management activities, including Hazard Analysis and FMEA.

Oversee regulatory compliance and product certification efforts for key global standards and regions.

Drive Product Standards Review Board activities and ensure adherence to evolving regulatory landscapes.

Review and approve critical technical documentation, including Technical Files and Design History Files.

Ensure regulatory and product safety oversight throughout the entire Design Control process.

Collaborate closely with Engineering, Quality, Regulatory Affairs, and Manufacturing teams to resolve compliance issues and implement improvements.

Support audits by providing essential technical expertise on product safety and quality systems.

Champion continuous improvement in regulatory compliance, product safety, and lifecycle engineering processes.

A Bachelor's or Master's degree in an engineering discipline like Electrical, Electronics, or Mechanical Engineering is required.

Bring a minimum of 10 years of experience in Product Safety, Regulatory Engineering, Design Controls, or a related technical field.

Possess a strong understanding of medical device regulations and standards, including IEC 60601, ISO 14971, ISO 13485, FDA, EU MDR, NMPA, and CDSCO.

Demonstrate extensive experience with Design Controls, risk management, and product lifecycle management.

Familiarity with EMI/EMC requirements and product certification processes is essential.

Experience supporting complex medical devices, ideally within the X-Ray Tube or Generator domain, is highly valued.

Key characteristics include strong technical leadership, exceptional problem-solving abilities, and outstanding communication skills for collaborating with global teams.