Product Safety Leader

Job Description Summary The Product Safety and Standards Compliance Engineer will be responsible for ensuring that all medical devices and related products adhere to applicable safety standards and regulations. The role involves conducting thorough safety assessments, identifying potential hazards, collaborating with design teams to mitigate risks, and maintaining compliance throughout the product lifecycle. This position is crucial for prioritizing patient safety and ensuring regulatory adherence within the healthcare industry.
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:

Risk Assessment and Hazard Identification:

• Perform detailed safety analyses on new and existing medical devices to identify potential hazards and assess their associated risks using methodologies like Failure Mode and Effect Analysis (FMEA) and other risk management tools.
• Conduct thorough reviews of product designs, materials, and manufacturing processes to identify potential safety concerns.

Compliance with Regulatory Standards:

• Stay updated on relevant international and national healthcare regulations (e.g., FDA, ISO 13485, IEC 60601) and ensure products comply with all applicable standards.
• Develop and maintain compliance documentation, including technical files, risk management plans, and product safety reports.

Design Input and Collaboration:

• Work closely with product development teams to integrate safety considerations into product designs from the early stages of development.
• Provide technical expertise on safety standards and regulations to engineering teams to ensure safe product design and implementation.

Testing and Certification:

• Oversee product testing and certification processes to verify compliance with safety standards, including collaborating with external testing laboratories.
• Analyze test results and interpret data to identify potential safety concerns.

Incident Investigation and Corrective Action:

• Investigate reported product safety incidents, analyze root causes, and implement appropriate corrective actions to prevent recurrence.
• Monitor post-market surveillance data to identify safety trends and take proactive measures to address potential issues.

Training and Awareness:

• Conduct training programs for cross-functional teams on product safety principles, regulatory requirements, and risk management practices.

Required Skills and Qualifications:

• Bachelors degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• Strong understanding of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601).
• Expertise in risk management methodologies and tools.
• Excellent analytical and problem-solving skills.
• Strong communication and collaboration skills to work effectively with cross-functional teams.
• Experience with product development lifecycle and design control processes.
• Ability to stay updated with emerging safety standards and regulatory changes.

Preferred Qualifications:

• Master s degree in a related field.
• Certification in quality management systems or risk management.
• Prior experience in a similar role within the healthcare or medical device industry.

Working Conditions:

• Office environment with occasional travel to manufacturing sites, testing laboratories, and industry conferences.
• Ability to work in a fast-paced and dynamic environment with strict regulatory timelines.

Additional Information