See below for the job description. You can submit your resume to me or submit it online at http://www.ge.com/jobsearch/ <http://www.ge.com/jobsearch/> (using job number 1081929). I will only submit resumes for those who are qualified.
Please note that I am not the hiring manager but rather a counterpart to this position in another part of the business. Regards, Nick Momcilovic Product Compliance Lead Engineer GE Healthcare Magnetic Resonance Product Safety Engineer Job Number: 1081929 Date Posted: 09 April 2010 Function: Engineering/Technology - Product Design and Development Business: GE Technology Infrastructure - Healthcare Career Level: Experienced Location: Waukesha, Wisconsin, United States About Us GE Healthcare provides transformational medical technologies that are helping a new age of patient care. GE Healthcare’s expertise in medical imagine and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients. GE Healthcare offers a broad range of products and services that are improving productivity in health and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. GE is an equal opportunity employer. Role Summary/Purpose A Product Safety Engineer, as part of the overall CT Hardware Engineering team, works to ensure that new and existing CT Premium products are designed to meet all of the safety and compliance requirements for the global markets where our products are sold. Essential Responsibilities Duties include (but are not limited to): - Ensure that IEC, UL, and other requirements are included in the design inputs and fully covered during verification and validation of the product. - Help guide the design, participate in technical reviews, and monitor on-going changes after product release. - Coordinate testing and certification with Nationally Recognized Testing Laboratories (NRTLs) and other government agencies globally. This includes compiling product documentation and leading onsite-testing activities. May require periodic domestic or international travel. - Create test procedures and author test reports for safety and compliance requirements not covered by NRTL or 3rd party agencies - Work closely with the NRTLs to complete periodic audits and maintain certification reports for the various CT Premium product lines. - Determine requirements and strategy to implement compliant product labeling - Drive engineering initiatives to address new safety, reporting, labeling, and design requirements as needed. - Collaborate with global CT engineering counterparts to share best practices, coordinate changes across product lines, and leverage CT platform commonality for maximum efficiency. Qualifications/Requirements Open to internal and external employees - B.S. in Electrical or Mechanical Engineering, or B.S. in a related technical discipline or 10+ years experience with an Associate - 5 or more years of combined product safety, regulatory, and/or engineering product development experience - 1 or more years of project leadership experience - Willing to travel, including international travel, 1-3 weeks per year as needed U.S. (Country) Specific Qualifications: - Must be legally authorized to work in the United States full-time - Must be willing to work in our Waukesha, WI facility full-time - Must be willing to submit to a drug test, and background check – to include verification of previous employment, criminal history and educational background. - Must submit application for employment through gecareers.com (or COS if internal) to be considered. - Must be 18 years of age or older. GE will only employ those who are legally authorized to work. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen. Desired Characteristics - Prior experience working for a National Laboratory (UL, ITS, CSA, etc.) - Experience in the medical device industry - 3+ years of project/program leadership experience with proven influence and organizational skill - Excellent teamwork, coordination and communication skills. Ability to work in a global team environment - Experience designing for compliance to FDA Medical Device regulations (21CFR Parts 820, 814 - 5+ years of product development experience, including electro-mechanical products and medical device - Experience with ISO 14971 (Risk Management - Advanced technical degree (M.S.) - Previous design experience with GE Healthcare products, including use of our design tools and quality processes - Healthcare experience - Fluent in written and oral English - 3 or more years experience with IEC 60601 compliance, including collateral, particular, and performance standards. - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. 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