Senior Systems Engineer - Safety Process Standards
Location:
Various, WI
Posted:
October 22, 2016
Position Type:
Full Time
Category:
Quality Assurance
Reference:
2760846
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 Healthcare at http://www.gehealthcare.com provides transformational medical

technologies and services to meet the demand for increased access, enhanced quality and more affordable

healthcare around the world. GE works on things that matter - great people and technologies taking on tough

challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery,

biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps

medical professionals deliver great healthcare to their patients.

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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.

Role Summary:

The Senior Systems Engineer is responsible for the technical operations of the Safety Lab, which supports Safety compliance testing of customer products. The individual leads the Global Labs team in developing a Safety Testing process to meet the needs of the Global Imaging business.; tests medical devices and systems per the requirements of IEC 60601-1, Medical Design Standards-3rd Edition, IEC particular and collateral Standards.

Essential Responsibilities:

Duties include (but are not limited to):

1. Setup and support datasheets, lab space, equipment management system, and test procedures to successfully conduct internal testing of customer products per submitted Safety Test Plans and associated standards:

2. Assists customers in identifying and solving Safety related issues

3. Review and Consult on Safety Product Test Plans.

4. Facilitate and oversee operations to create Safety Test Data Reports for submission to Modality Safety Leader.

5. Maintain training and competency level required to manage and maintain equipment and perform testing per the appropriate standards and procedures.

6. Oversee Safety Laboratory test equipment:

a) Assure all equipment is maintained, calibrated and controlled to support lab operations.

b) Validate and manage operation of all automated equipment and test control software per necessary requirements.

c) Identify and source new equipment needs per changes and additions to the Safety test standards and within budgetary goals.

d) Owns the Corrective and Preventive Actions process for safety lab operations.

7. Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible. Partner with internal and external stakeholders as necessary.

8. Mentor and Assist with training of Global Safety Lab Technicians to assure competency level of individuals performing Safety tests are appropriate per the relevant standards and procedures.

9. Represent GEHC on USA and IEC TC62 TAG and TC62A for the continued maintenance and updates for IEC 60601-1 General Standard. Partner with SMEs on Collateral and Particular standards and other associated standards where necessary to achieve business goals.

10. Monitor the current and evolving global regulatory environment to identify proposed, new or changing product performance and regulatory standards that could impact the company's medical devices

11. Analyze and communicate proposed, new or changing requirements, and lead teams to devise strategies for their implementation.

12. Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance.

13. Lead and work closely with regulatory and other professionals across the company to develop company-wide programs and processes for determining the applicability and implementation of global standards.

14. Leverage similarly across multiple GEHC sites as needed to optimize business goals.

15. Lead, mentor, coach, teach, and develop employees within the team.

Quality Specific Goals:

1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

2. Complete all planned Quality & 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 for test laboratory within area of responsibility to ensure laboratory accreditations are maintained

5. Complete all tests in compliance with procedures and regulations

6. Complete all planned Quality & Compliance training within the defined deadlines

7. Identify and report any quality or compliance concerns and take immediate corrective action as required

8. Effectively support implementation & training of current regulatory requirements

Qualifications/Requirements:

1. Bachelors degree in Engineering, Biomedical Engineering, Physics, Chemistry or closely related discipline; or equivalent (defined as a High School Diploma/GED and 4 years relative work experience)

2. 7 years' experience product design and development

3. Broad exposure to HW/SW/Systems design, and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc)

4. Knowledge of Safety regulation: IEC 60601-1, Collateral and Particular

5. Awareness of Local and International Regulatory Agencies

6. Knowledge of a New Product Introduction process

7. Knowledge of Quality Management Systems including IEC/ISO 17025

8. Demonstrated ability to pursue tasks to completion and manage multiple activities effectively.

9. Ability to communicate effectively with engineers from different disciplines and varying levels of experience.

10. Proven ability to develop timely and effective solutions for challenging design problems

Desired Characteristics:

1. Previous experience in an ISO/IEC 17025 accredited lab

2. 5 years' experience in the regulated medical device industry

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

4. Strong organizational skills with high attention to detail

5. Adaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations

6. Excellent team-player skills w/global mindset

7. Excellent interpersonal, organizational, communication and influencing skills

8. Working knowledge of GEHC products

9. Strong people networking skills.

10. Effective team player with motivating skills.

11. Strong working knowledge of English language (oral and written)

12.Clear thinker, action oriented, high energy, self-starter.

Locations: United States ; Wisconsin; Waukesha, Remote

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.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.
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