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General Electric Safety & Regulatory Engineer in Wuxi, China

Job Description Summary

Systems engineering is a cross-functional engineering discipline centered on an approach, mindset, and process. All activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the users needs. The discipline that executes a robust process of design, creation, and optimization of systems, consisting of identification and quantification of system requirements, creation of alternate system design concepts, performance of design trade studies, selection and implementation of the best designs and verification that the design is properly integrated and executed. Process that proceeds from concept to production to operation.

Impacts quality of own work and the work of others on the team. Executes standard operational/technical tasks typically subject to instructions and work routines. There is latitude to rearrange the sequence to complete task/duties based on changing work situations.

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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

Roles and Responsibilities

  • Reviews and understands the applicable standards required by Law in country that apply to the relevant products. Communicates standards to the design community and maintains it. May also participate with independent third parties to perform product compliance and certification work (testing, design review etc.) and communicates results/actions to the relevant engineering and supply chain team. Interacts with outside engineering firms or governmental agencies to provide or record product compliance to required regional or national standards to gain the needed product certification or qualification.

  • Broadening knowledge of own technical discipline to execute policy/strategy. May include support roles with specialized technical field of knowledge; still acquiring higher level knowledge and skills.

  • Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area.

  • May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good technical knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined instructions/parameters.

  • A job at this level requires good interpersonal skills and may be required to lead a junior team. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Explains technical information to others.

Required Qualifications

  • Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Physics, Chemistry or closely related discipline

  • 5 years relevant work experience

  • Ability to prioritize, plan & evaluate deliverables

  • Knowledge & experience conducting design, regulatory.

Desired Characteristics

  • Strong oral and written communication skills. Ability to document, plan, market, and execute programs.

  • Master’s degree in Physics, Electrical Engineering or Biomedical Engineering

  • Strong working knowledge of Medical Device regulations, CFDA/FDA/MDD/MHLW

  • Experience with IEC 60601 standard.

  • Excellent interpersonal, organizational, communication and influencing skills

  • Demonstrated problem solving ability and results orientation

  • Knowledge of Quality Management Systems (QMS).

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.

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Additional Information

Relocation Assistance Provided: No

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