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General Electric Product Safety Regulatory Engineer in Hino, Japan

Job Description Summary

Job Description

The CT Product Safety Regulatory Engineer will own safety and regulatory related design and tests for CT products to compliant with IEC standard and country requested regulatory requirements. CT Product Safety Regulatory Engineer is considered as an expert in product safety and regulatory requirements/tests in the medical device systems, and leading ad executing required tasks by leveraging wealth of technical experiences and knowledges. Also, this role requires Quality Management System knowledge and Risk Management.

Roles and Responsibilities

GE Healthcare develops industry-leading CT technologies & innovations to deliver applications & imaging capabilities that enable physicians and radiologists to improve the level of patient care. As a CT Product Safety Regulatory Engineer, you will become a leader to take on the responsibility in CT Safety and Regulatory related product design, and work with Regulatory/Quality Affair team to deploy the required standard and requirements to the performance segment scanners as well as software medical devices. You will report directly to the CT Systems Engineering Manager.

Key Responsibilities Include (but are not limited to):

  • Working with global CT systems team, cross-functional engineers to define associated requirements, regulatory related impacts, and system level risks for new products

  • Working with RA/QA team as well as related external experts like for ITS test for the new product introductions

  • Using broad technical expertise and experience to help resolve to align new standard and regulatory requirements accordingly

  • Providing domain expertise to own/lead technical design reviews, investigation of technical risks to clear regulatory requirements for the system deployment to the market.

  • Providing technical leadership for project execution

  • Driving impact assessments of updated IEC standard and regulatory requirements for each related country.

  • Driving the design and execution of system level tests for related system level requirements.

  • Working with RA/QA team closely for product audit activities.

Required Qualifications

  • Bachelor's degree in Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics, Medical Physics or a closely related field

  • More than 7 years development experiences in clinical medical devices.

  • More than 5 years safety and regulatory related experiences for clinical medical devices.

  • Strength in IEC standard and product regulatory knowledges

  • Effective communication skills - ability to present ideas clearly and concisely.

  • Demonstrated ability to pursue tasks to completion

  • Demonstrated problem solving ability and results orientation

  • Demonstrated ability to work in a collaborative, matrixed, and customer focused environment

  • Fluent level Japanese and business level English communication skill to work with global team and auditors.

  • Must be legally authorized to work in Japan full-time

Desired Characteristics

  • Imaging Medical device development experience

  • X-ray medical device development experience

  • Regulatory / IEC standard safety test experience

  • Excellent oral and written communication skills

  • Self-starter, energizing, results oriented, and able to multi-task

  • Demonstrated problem solving ability and results orientation

  • Demonstrated technical leadership capability in product integration activities.

  • Demonstrated ability to work in a collaborative, matrixed, and customer focused environment

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