General Electric EMC Leader in Waukesha, Wisconsin

Role Summary:

The EMC Leader oversees the day-to-day operation of the local Electro-Magnetic Compatibility (EMC) Laboratory and provides training and guidance to the EMC Technicians, EMC Specialists and EMC Engineers relative to performing EMC compliance testing of customer products. The EMC Lab primarily tests medical devices and systems per the requirements of IEC 60601-1-2.

Essential Responsibilities:

Assure the quality of EMC Laboratory testing per the requirements of the appropriate regulating Standards:

 Understand laboratory operations and personnel competency requirements as required under the GE Healthcare Quality System, ISO/IEC 17025 quality system requirement for test laboratories and IEC 60601-1-2 and other relevant EMC test Standards.

 Maintain laboratory accreditations and interface with internal and external auditors

 Review and approve all EMC test plans and reports

 Stay current on relevant Standards and assess laboratory impacts of changes and additions

 Oversee EMC Laboratory day-to-day operations

 Interface with Customers in arranging testing. Clarify Customer’s facility and test needs to assure laboratory meets customer’s requirements.

 Provide guidance to customers regarding EMC regulations requirements:

 Define test input requirements and work with Customers in completing appropriate test plans

 Manage EMC test schedules and assign responsible test personnel

 Oversee and direct laboratory personnel work tasks

 Assist Global EMC Manager with creation of yearly budget and equipment needs

 Provide training of EMC Technicians, EMC Specialists and EMC Engineers to ensure competency level of individuals performing EMC tests are appropriate per the relevant Standards and procedures

 Take ownership of any Wireless Testing that will be conducted in the EMC Lab. This includes but is not limited to – ANSI C63.27, AIM Standard 735173 and IEC 61000-4-39

 Get A2LA accreditation to ANSI C63.27, AIM Standard 735173 and IEC 61000-4-39

Quality Specific Goals

  1. Be aware of and comply with the GEHC Quality Manual, Quality Management System including EMC lab specific Quality System Regulations (QSR), Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

  2. Complete all planned Quality and Compliance training within the defined deadlines

  3. Identify and report any Quality or Compliance concerns and take immediate corrective action as required

  4. Keep up-to-date on knowledge and understanding of current regulatory requirements within area of responsibility to ensure laboratory accreditations are maintained

  5. Effectively support implementation, training and management of current regulatory requirements in EMC testing

  6. Maintain lab accreditation

Qualifications/Requirements:

• Bachelor’s degree in Electrical Engineering, Electrical Engineering Technology, Physics or related field with a minimum of 3 years’ experience with EMC testing;

OR a minimum of 10 years’ experience in an engineering or compliance testing role and 5 years’ experience with EMC testing;

• Knowledge of IEC 60601-1-2 EMC Standard for Medical Devices

• Knowledge of ISO/IEC 17025 Standard for Testing and Calibration Labs

• Knowledge of Quality Management Systems

• Leadership skills; experience providing work direction to lower-level or more junior employee

• Strong working knowledge of Microsoft Word, Excel and Power Point

• Strong analytical and problem-solving skills

• Ability to interpret technical writing documents (i.e. Engineering and Manufacturing)

• Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others

 Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations

 Knowledge of ANSI C63.27 Evaluation of Wireless Coexistence

 Knowledge of AIM Standard 7351731 - Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers

 Knowledge of IEC 61000-4-39 - Testing and measurement techniques – Radiated fields in close proximity – Immunity test

Desired Characteristics:

• NARTE certified engineer

• Strong working knowledge of English language (oral and written)

• Participated on an IEC 60601-1-2 or associated Standard committee

• Previous experience in an ISO/IEC 17025 accredited EMC lab

• Previous work experience in a medical device industry

• Knowledge of process improvement tools (six sigma, lean, ISO, TQM)

• Strong organizational skills with high attention to detail

• Ability to manage multiple activities effectively

• Ability to work effectively on cross-functional teams

• Highly motivated self-starter, able to work on own initiative and well in a team environment

 Adaptable/Flexible: Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations

 Knowledge of the Radio Equipment Directive (RED 2014/53/EU)

 Knowledge of FCC Code of Federal Regulations (CFR) Title 47

About Us:

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.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.

Locations: United States; Wisconsin; Waukesha

GE will only employ those who are legally authorized to work in the United States for this opening.