Job Description Summary

Job Description

Job Responsibilities:

• Lead and execute safety risk management activities for new product development and sustaining engineering projects including hazard identification risk analysis and risk control verification.

• Interpret and apply relevant global medical device regulations and standards (e.g. FDA MDR IEC 60601-1 and other applicable standards) to product design and development.

• 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

• 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

• Support EPCs Technical Files 510(k) CE and regional submission documentation.

• Discuss with test sites (TUV MECA NRTL CB) and internal QA to clarify if/which test are needed for changes on safety related parts. Document tests and rationale for No-test-needed as applicable along with product variability assessment.

• Risk management for device design: Develop and maintain regulatory documentation including regulatory submissions technical files and design history files ensuring compliance with applicable standards.

• Collaborate with design manufacturing quality and clinical teams to integrate safety and regulatory requirements into product development processes.

• Conduct post-market surveillance activities including complaint handling incident reporting and field action assessments to ensure ongoing product safety and regulatory compliance.

• Participate in internal and external audits providing expertise on safety and regulatory matters.

• Stay abreast of changes in global medical device regulations and standards assessing their impact on Wipro GE Healthcare products and processes.

• Mentor and provide technical guidance to junior engineers on safety and regulatory matters.

• Drive continuous improvement initiatives within the safety and regulatory engineering function.

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

Job Qualifications:

• Minimum Bachelors degree in Biomedical Engineering Electrical Engineering Mechanical Engineering or a related scientific discipline. Masters degree preferred.

• Minimum of 8 years of experience in safety and regulatory engineering within the medical device industry.

• Demonstrated expertise in applying ISO 14971 (Application of risk management to medical devices) and IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance).

• Strong understanding of global medical device regulations including FDA QSR EU MDR and other international standards.

• Proven track record of working with safety standards such as IEC60601 REACH RoHS and WEEE CE Mark Technical Files.

• Expertise in electromagnetic compatibility (EMC/ESD) debugging and fixing.

• Proven ability to lead and manage complex safety and regulatory projects.

• Excellent written and verbal communication skills with the ability to effectively communicate technical and regulatory information to diverse audiences.

• Strong analytical and problem-solving skills with a keen attention to detail.

• Ability to work independently and as part of a cross-functional team in a fast-paced environment.

• Strong organizational and project management skills. Ability to plan organize and execute tests and audits efficiently.

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.

Additional Information