General Electric Senior Systems Engineer - Standards and Regulatory in Madison, Wisconsin
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 departmental operations and responsible for planning/execution. The role has some autonomy but is focused on execution of activities within an operating discipline covered by standard functional practices and procedures. Some judgment may be required but this is typically with guidance.
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.
IEC 60601 – Safety & EMC standards compliance (incl. particular standards) and ATM (Authorization to Mark) labels (ETL/CSA/Inmetro) - plan, quote, execute and approve reports for external lab test bodies.
Be familiar with the standards/WI including ISO 14971.
Work closely with the test bodies (SII, Hermon, CSA/ETL/Inmetro etc.).
Follow up on reports update following design changes.
Gap analysis of new standards and support implementation.
Escort NPIs from design phase.
Expertise in 21CFR\CDRH applicable clauses.
Regulatory agencies and onsite testing (CFDA, KFDA, MHLW, etc.) – plan (prepare PRS), execute, communicate and approve reports.
Represent ARC in the Global standards organizations.
Engineering representative in regulatory periodic review (CCN process) – Own the transfer from regulation to engineering design actions.
Create database of applicable standards to assist design inputs for New Product Introductions (NPIs), including Bi-annual updates -
Trainings - train engineering upon changes in standards, as applicable. Support local Quality Management System updates as required.
Support annual production inspections and reports (e.g. CDRH).
Cross programs regulatory labels alignment – requirements, labels suppliers, transfer to production Regulatory ECOs .
Engineering representative for standards driven changes.
Approver of ECR\ECO for applicable design change.
Developing in-depth knowledge of a technical discipline.
Uses prior experience and acquired technical expertise to execute policy/strategy.
In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, Computer), Computer Science or similar technical discipline or Associate’s degree with 8 years of technical experience.
Minimum 5 years of experience in Design Engineering.
Demonstrated competency in understanding functionality of complex systems including mechanical (pneumatic and structural), electrical, and software designs and their integrated interactions.
Demonstrated experience working with a multi-discipline, global team.
Demonstrated oral and written communication skills.
Strong Microsoft Office skills (especially Excel).
Experience in design engineering for Anesthesia Systems, Critical Care Ventilators, or other life support devices.
Experience in design verification of complex systems.
Experience in medical device standards and regulations.
Experience with requirements management tools such as DOORs.
Experience in systems architecture and integration for complex systems.
Experience in design engineering for medical devices.
Master’s degree in a technical field.
Ability to work in a high paced, dynamic, global environment.
Independent by nature, Self-learner, Excellent communication skills.
Strong organizational skills with high attention to detail.
Strong analytical and problem-solving skills.
Ability to interpret technical documents (i.e. Engineering and Manufacturing).
Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations.
Ability to manage multiple activities effectively.
Ability to work effectively on cross-functional teams.
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.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf) . 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