GE HealthCare is looking for an energetic Safety and Regulatory Engineer (SRE).

As a Safety & Regulatory Engineer you will be responsible for ensuring compliance of our products to regulatory requirements. You will work closely together with both engineering and commercial teams to support the development of new products, participating in risk analysis, design reviews and testing activities.
You will also coordinate technical documentation for the Notified Body approval process. Furthermore, you will provide safety advice to other departments and external customers, represent the department at internal and external meetings, and follow up complaints regarding product safety.
The Safety and Regulatory Engineer (SRE) shall support and ensure that all safety and regulatory requirements are implemented in the development of our ultrasound products.

Areas of responsibilities and tasks:

• Support R&D personnel for Safety and Regulatory related questions and issues

• Mechanical, environmental, and electrical safety, and electromagnetic compatibility (EMC/ESD)

• Material compliance to REACH, RoHS and WEEE

• Parts classification

• Usability analysis and Systems Development Life Cycle (SDLC) for software applications

• Risk management for device design

• Plan, organize and execute Informative tests when needed, and formal tests by external test houses according to norms like IEC60601 family of standards, including their national deviations

• Be the main engineering contact for Product Certification Bodies and Test houses

• Discuss with test sites (NRTL, CB) and clarify if/which test are needed for changes on safety related parts. Document tests and rationale for ‘No-test-needed’ as applicable

• Work closely with Regulatory Affairs and Quality Management for efficient implementation of new regulations, participate in audits (internal, external) when applicable

Educational Background:

• Bachelor's or Master's degree in Engineering, Biomedical Engineering, or a related field.

Experience:

• Proven experience in safety and regulatory engineering, preferably in the medical device industry.

• Proven track record of working with safety standards such as IEC60601, REACH, RoHS, and WEEE.

Technical Skills:

• Strong knowledge of mechanical, environmental, and electrical safety.

• Expertise in electromagnetic compatibility (EMC/ESD).

• Proficiency in risk management and usability analysis.

• Familiarity with Systems Development Life Cycle (SDLC) for software applications.

Regulatory Knowledge:

• In-depth understanding of regulatory requirements and compliance processes.

• Experience in coordinating with Product Certification Bodies and external test houses.

Communication Skills:

• Excellent verbal and written communication skills.

• Ability to effectively collaborate with R&D teams, regulatory affairs, and quality management.

Organizational Skills:

• Strong organizational and project management skills.

• Ability to plan, organize, and execute tests and audits efficiently.

• Competitive Salary: We offer a competitive salary package that reflects your skills and experience.

• Comprehensive Benefits: Enjoy a comprehensive benefits package including health insurance, retirement plans, and paid time off.

• Professional Development: We support your growth with opportunities for professional development, training, and certifications.

• Innovative Environment: Work in a dynamic and innovative environment where your contributions make a real impact on the development of cutting-edge ultrasound products.

• Collaborative Culture: Join a team-oriented culture that values collaboration, diversity, and inclusion.

• Work-Life Balance: We understand the importance of work-life balance and offer flexible working hours and remote work options.

• Career Advancement: Opportunities for career advancement and growth within the company.

• Employee Well-being: Access to wellness programs and resources to support your overall well-being.

• Industry Leader: Be part of a leading company in the medical device industry, known for its commitment to quality and innovation.

• Impactful Work: Contribute to the development of life-saving medical technologies that improve patient outcomes.

• Supportive Team: Work with a supportive and experienced team that values your input and expertise.

• Cutting-Edge Technology: Engage with the latest technologies and methodologies in the field of safety and regulatory engineering.

• Positive Work Environment: Enjoy a positive and inclusive work environment where your efforts are recognized and rewarded.