Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Our location in Irving, TX
, currently has an opportunity for an EMC Product and Safety Engineer WHAT YOU'LL DOGeneral Job Description:
The EMC Product and Safety Engineer applies an interdisciplinary, collaborative approach to ensure and verify the design of the subsystems integrated together function optimally as a system in accordance with EMC and Safety standards in compliance with Abbott quality and regulatory guidelines and procedures.
In this role the candidate:
Specific Job Description
- Develops and executes EMC and Safety test plans for complex medical device systems
- Defines appropriate test plans and test methods based on EMC and Safety stands
- Collaborates with peers and Cross Functional Teams on project designs
- Participates in system, software, hardware design reviews and test planning reviews to support assessment of performance against design specifications and EMC and Safety standards.
The EMC and Safety Engineer performs EMC and Safety assessments for new product development and on market product changes. Writes and executes EMC/EMI Test Plans/Procedures and Reports based on IEC/EN 61326, and other applicable external standards. Writes and executes Safety Test Plans/Procedures and Test Reports based on UL/CSA/IEC 61010 and 60950. Applies quantitative methods, analyzes data, evaluates results, forms conclusions. Performs troubleshooting to identify and confirm causes behind multiple system functions (i.e., hardware and software, etc.) issues, discrepancies, problems, or complaints in accordance with governing procedures. Evaluates technical risks and identifies mitigations and/or recommendations for resolution and management reporting. Proactively identifies opportunities for significant operational process or system level product improvements. Independently manages their assignments and provides resource estimates and related impact of project scope.
Candidate may be required to work instrument outside of the normal business hours.
Travel as necessary to execute testing, participate in training classes or other business-related meetings (5%).Responsibilities:
EDUCATION AND EXPERIENCE YOU'LL BRINGRequired
- Participates in a systems-level approach to EMC and Product Safety compliance for new product development and existing product by collaborating with ICHP, Hematology, Transfusion, Molecular, Abbott POC, ARDx, Regulatory and Compliance organizations.
- Review requirement specifications for EMC requirements for new product proposals and assist with EMC design portion of instrument per design specification by participating in design reviews to provide detailed design guidance on filters, shielding of ventilation, gaskets, transient protection needs, cable shielding, etc.
- Set up and conduct EMC/EMI testing with minimum assistance based on IEC/EN 61326-1, IEC/EN 61326-2-6, and other applicable external standards. Set up and conduct safety testing with minimum assistance as required per UL/CSA/IEC 61010 and UL/CSA/IEC 60950.
- Writes EMC/EMI Test Plans/Procedures and Reports based on IEC/EN 61326-1, IEC/EN 61326-2-6, and other applicable external standards. Write Safety Test Plans/Procedures, Test Reports and perform Safety assessments based on UL/CSA/IEC 61010 and 60950.
- Perform EMC/EMI and Safety testing and troubleshoot problems as needed and recommend cost effective solutions with minimal design impact. Independently troubleshoots multiple issues to determine root cause and proposing possible solutions.
- Set up and operate on-site EMC Lab and environmental chambers according to pre-approved test protocols. Performs troubleshooting of test equipment and equipment under test (EUT) and documents all performance issues as they occur. Set up and perform acoustic testing per applicable acoustic test standards
- Interact with external certifying agencies during the creation and maintenance of UL Files, CB Scheme and CE Marking Technical Files.
- Perform safety risk assessments per ISO 14971, and regulatory compliance reviews on new designs and existing design changes.
- Perform Regulatory Assessments and maintain all regulatory compliance documentation from a global perspective to ensure accurate and up to date adherence to set standards.
- Research and stay current with the latest EMC and Safety regulatory standards.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Bachelor's Degree in Electrical, Mechanical, Biomedical Engineering or Physics or related Science, Technology, Engineering, and Mathematics (STEM) discipline from an accredited college or university.
- 5 years' experience relevant experience EMC and Product Safety testing or related engineering discipline.
- A proven self-starter with the highest level of integrity in the successful completion of your work.
- Strong technical background and knowledge of the EMC testing and/or Product Safety standards
- Moderate oral and written communication and documentation skills.
- The ability to work co-operatively and effectively with others to establish and maintain good working relationships.
- Must be able to collaborate with multi-disciplinary groups and functions on site.
- Ability to interface with external certification agencies.
- Familiarity with EMC/Safety test equipment and methods, and general laboratory test equipment.
- Ability to adapt and work in a FDA regulated environment.
- Experience with executing test plans for complex electro-mechanical systems.
- Knowledge of regulations, standards and Directives affecting the IVD medical device industry is a plus.
- Pro-active problem-solving skills.
- Knowledge of basic project management concepts
WHAT WE OFFER
- Experience independently leading project activities and demonstrates decision making skills.
- Demonstrated success in technical proficiency, creativity, and independent thought.
- Experience with root cause analysis
- Hands on experience with diagnostic medical equipment in a laboratory environment
- Experience with Alinity instrument, assay and/or commodity development principles and concepts.
- Experience with Requirement analysis and decomposition and Risk Management
- Hands on customer experience
- Prior medical device experience: electro-mechanical, chemical, or biochemical technologies as they pertain to the design, integration, evaluation, and commercialization of diagnostic systems.
- Experience implementing various product and process improvement methodologies (e.g. Six Sigma and Lean Manufacturing)
At Abbott, you can have a good job that can grow into a great career. We offer:
Learn more about our benefits that add real value to your life to help you live fully:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- Pension Plan
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.