Lead Systems Engineer - Safety and Regulatory
Waukesha, WI 
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Posted 1 month ago
Position No Longer Available
Position No Longer Available
Job Description
Job Description Summary The Safety and Regulatory Lead Systems Engineer role is a key position within the Systems Engineering team. The successful candidate is expected to demonstrate strong leadership skills by working closely with design engineering team, regulatory team, complaint handling team, service team and field personnel to drive MR products compliance to standards and regulations. This role involves execution as an individual contributor as well as opportunities to grow into project leadership.Job Description Roles and Responsibilities Drive design for product safety and regulatory compliance for global MR products.Support design teams with applicability of requirements and test plans from international and country specific regulations like Medical Device Directive, FDA, KFDA, NMPA, IEC 60601 standards.Support safety and regulatory aspects of Complaints, Investigations, CAPAs, Audits, Engineering Design Changes, Supplier Changes and Cost Reduction Projects to existing MR products.Develop engineering guidelines and provide training to engineering teams around safety and regulatory compliance in MR system design.Provide input on standards development activities to IEC, NEMA technical committees.Guide the cross-functional and cross-segment team through planning and execution to achieve project goals. Define project deliverables. Manage schedule, budget, resources, and materials.Responsible for delivering updates on the project progress and possible obstacles. Identify problems early and escalate to MR Leadership, as needed.Work independently to complete and execute project tasks with limited guidance.Provide support to manufacturing and field issues, as needed.Ensure that the project development process abides by all defined cross-functional standards, meets the intent and letter of Phased Review Discipline and all compliance and regulatory needs of the applicable markets.Required Qualifications Bachelor's Degree in Engineering/Science or closely related field.4 years relevant work experience in Engineering or Life Sciences: Biomedical Engineering, Electrical Engineering, Computer Science, Chemistry, Physics, or a closely related field.Project leadership experience within an engineering, manufacturing, or research environment.Excellent teamwork, coordination, influencing and communication skills.Ability to develop timely and effective solutions for challenging design problems.Ability to develop unique concepts/solutions for complex projects.Strong sense of accountability and ownership.Desired Characteristics Advanced Degree in Engineering/Science: Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Medical Physics, or closely related field.Broad exposure to MR hardware/software/coils/applications/system design; technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.)Experience with MR scanner operation.Ability to analyze complex issues and decompose these into a manageable set of tasks.Knowledge of GE Healthcare MR products.Knowledge of GE Healthcare engineering tools and processes.Knowledge of the GEHC Quality Management System.Experience with engineering design and development for MRI systems using Electromagnetic field, Electromagnetic compatibility (EMC), and Digital and RF design theory.Knowledge of international and country specific regulations like Medical Device Directive, FDA, KFDA, NMPA, IEC 60601 standards.GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer . 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.GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).Relocation Assistance Provided: Yes

 

Position No Longer Available
Job Summary
Company
GE Healthcare
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
4+ years
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