Job Description Summary

As a Lead Engineer 1 - Safety & Regulatory Engineer, you will be responsible for ensuring the safety and regulatory compliance of Wipro GE Healthcare's medical devices throughout their lifecycle. This role involves leading safety risk management activities, interpreting and applying global medical device regulations, and collaborating with cross-functional teams to achieve regulatory approvals and maintain product safety. You will also coordinate technical documentation for the Notified Body approval process.

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 Bachelor's degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related scientific discipline. Master's 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 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.

Additional Information