Architect – Product Safety & Regulatory Engineering

Job description

Job Description Summary Lead Product Safety, Regulatory Compliance, Risk Management, and Design Controls for GE HealthCare's X-Ray Tube and X-Ray Generator portfolio across the entire product lifecycle. This role provides technical leadership to ensure new and installed-base products meet global safety, regulatory, and quality requirements while supporting product enhancements, design changes, supplier transitions, and lifecycle engineering initiatives. The Architect partners with cross-functional global teams to drive compliant product development, regulatory approvals, and risk-based decision making that enables safe, reliable, and innovative medical imaging solutions. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Key Responsibilities ​Provide technical leadership for Product Safety, Regulatory Compliance, Risk Management, and Design Controls for X-Ray Tubes and X-Ray Generators across new product development and lifecycle engineering activities. Evaluate the impact of engineering, supplier, component, and manufacturing changes to ensure continued compliance with global regulatory and product safety requirements. Lead product risk management activities, including Hazard Analysis, Risk Assessments, Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), and Product Safety Reviews. Lead regulatory compliance and product certification activities, including support for IEC 60601, ISO 14971, ISO 13485, FDA, EU MDR, NMPA, CDSCO, UL, CSA, ETL, RoHS, REACH, and other applicable regional requirements. Drive Product Standards Review Board (PSRB) activities, Country Compliance Notifications (CCN), and regulatory assessments to address evolving global regulatory requirements. Review and approve technical documentation including Technical Files, Design History Files (DHF), Device Master Records (DMR), Risk Management Files, product specifications, labeling, user documentation, and compliance records. Provide regulatory and product safety oversight throughout the Design Control process, including Design Inputs, Design Outputs, Verification, Validation, Design Transfer, Engineering Change Requests (ECRs), and Engineering Change Orders (ECOs). Collaborate with Engineering, Quality, Regulatory Affairs, Manufacturing, Service, Supplier Quality, and Sourcing teams to implement compliant product improvements and resolve technical compliance issues. Support internal, external, regulatory, certification, and customer audits by providing technical expertise related to product safety, EMI/EMC compliance, regulatory requirements, and quality management systems. Drive continuous improvement initiatives that strengthen regulatory compliance, product safety, and lifecycle engineering processes across the X-Ray Generation product portfolio. Basic Qualifications Bachelor's or Master's degree in Electrical Engineering, Electronics Engineering, Mechanical Engineering, or a related engineering discipline. Minimum of 10 years of experience in Product Safety, Regulatory Engineering, Design Controls, Quality Engineering, Medical Device Compliance, or a related technical discipline. Demonstrated knowledge of medical device regulations and standards, including IEC 60601, ISO 14971, ISO 13485, FDA regulations, EU MDR, NMPA, CDSCO, and other applicable global regulatory requirements. Experience with Design Controls, design change management, risk management, verification and validation, product lifecycle management, and regulatory compliance. Working knowledge of EMI/EMC requirements and product certification processes. Experience supporting complex medical devices, preferably X-Ray Tubes, X-Ray Generators, medical imaging systems, or related electromechanical products. Desired Characteristics Strong technical leadership with a systems engineering mindset. Demonstrated ability to influence and collaborate across global cross-functional teams. Excellent analytical, problem-solving, and risk-based decision-making skills. Strong written and verbal communication skills with the ability to communicate complex technical concepts to diverse stakeholders. Experience balancing innovation, quality, regulatory compliance, and business objectives. Self-motivated with a continuous improvement mindset and strong execution focus. 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. Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. #LI-SB1 #LI-Onsite Additional Information Relocation Assistance Provided: Yes