Lead Product Safety Engineer

Job Description Summary

The Safety Engineer ensures product safety and regulatory compliance for GE HealthCare Surgery medical equipment throughout the product lifecycle. This position plays a critical role in ensuring patient safety and regulatory compliance across global markets. The Safety Engineer collaborates with cross-functional teams including design engineering, manufacturing, and quality assurance to integrate safety requirements early in the development process and maintain compliance throughout the product lifecycle.

The Safety Engineer ensures product safety and regulatory compliance for GE HealthCare Surgery medical equipment throughout the product lifecycle. This position plays a critical role in ensuring patient safety and regulatory compliance across global markets. The Safety Engineer collaborates with cross-functional teams including design engineering, manufacturing, and quality assurance to integrate safety requirements early in the development process and maintain compliance throughout the product lifecycle.

Job Description

Responsibilities

• Drive certification and compliance activities per IEC 60601-1 series and other relevant standards (IEC, CSA, FDA, EU, NMPA).

• Develop test plans and define scope and resources required for safety and regulatory testing.

• Perform and/or witness safety tests, review raw data, and author test reports.

• Interface with certifying agencies (CSA, NRTL) to ensure test scope, execution, and acceptance of results.

• Mentor engineers on safety standards, regulatory requirements, and testing protocols.

• Identify and resolve safety and compliance issues across the product lifecycle.

• Support recurring factory inspections and ISO 17025 accreditation for internal labs under WMTC / CB Scheme.

• Maintain up-to-date knowledge of evolving standards and regulatory requirements.

• Drive process improvements within safety engineering and ensure audit readiness.

Quality Responsibilities

This role requires close collaboration with Quality and Regulatory teams to ensure all compliance activities align with internal and external standards.

• Comply with GEHC Quality Manual, QMS, and applicable regulations.

• Complete all required Quality & Compliance training on time.

• Ensure accuracy, completeness, and archival of test data per QMS and Good Documentation Practices.

• Verify calibration and proper operation of test equipment.

• Maintain impartiality, confidentiality, and integrity in all testing activities.

• Follow EHS policies and proactively address safety concerns.

Required Qualifications

• Bachelor’s degree in Engineering, Physics, or related field and 5+ years experience with medical device development OR 10+ years in medical device engineering/compliance with 3+ years IEC testing experience.

• Working knowledge of IEC 60601-1 standards and medical device regulations.

• Understanding of ISO/IEC 17025 for testing and calibration labs.

• Familiarity with Quality Management Systems.

• Strong analytical, problem-solving, and leadership skills.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

• Experience with requirements management tools (e.g., DOORS, JAMA).

• Excellent English communication skills (oral and written).

Preferred Qualifications

• Hands-on experience with GEHC Surgery Mobile fluoroscopic X-ray C-arm systems.

• Understanding of risk management, usability, labelling, X-ray, electrical, mechanical, software, wireless, EMI/EMC, AI/ML, and environmental safety and regulatory compliance principles in complex systems.

• Prior participation in IEC 60601-1 committees and/or product safety societies.

• Experience in ISO/IEC 17025 accredited or IECEE-based CTF labs.

• Previous work in the medical device industry.

• Strong organizational skills and ability to manage multiple priorities.

• Familiarity with process improvement tools, automation tools, and digital solutions for safety process optimization.

• Adaptable/Flexible: Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations.

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We will not sponsor individuals for employment visas, now or in the future, for this job opening.

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.