Develop and maintain productive client relationships through professional services by applying safety standards and regulations to various medical electrical equipment and / or systems. The position is responsible for independently managing assigned project work including performing electrical and mechanical safety testing and construction reviews on a variety of medical products and documenting results as reports using standardized formats.
Objective
Provide proactive assistance to clients by identifying Medical Electrical Equipment (MEE) Safety issues, along with providing timely and accurate test reports and information to both internal and external clients.
Major Roles & Responsibilities
Sample Preparation
Understand, interpret, and apply the requirements and test methods of the main MEE General standard IEC 60601-1.
Knowledge and experience with various MEE Collateral and Particular standards (IEC 60601-1-XX and IEC 60601-2-XX or IEC / ISO 80601-2-XX series).
Understanding of ISO 14971 risk management process.
Understanding of risk management minimums as required by IEC 60601-1.
Understanding of IEC 60601-1-6 and IEC 62366-1 Usability Engineering Process
Evaluate and perform construction reviews on products submitted for Medical Product Safety testing.
Conducts testing on a variety of product samples using prescribed testing methods, following testing standards / specifications appropriate to the sample, providing direction to techs.
Accurately record test data and explain test methods and results to assist clients in understanding.
Train employees on sample preparation method and test methods.
Assist with department testing in other areas, providing direction, as required.
Prepares written technical reports and directly works with CB and NRTL reviewers.
Perform final review and interpret data / reports, providing direction, as required.
Organizes and monitors workload to meet or exceed laboratory turnaround time and client expectations.
Assist in the coordination of technical & administrative aspects of various departmental projects.
Provides technical consultation to internal and external clients.
Research and development of new testing services / methods / procedures / set-ups, in a limited capacity with direction from senior staff.
Calibrate, operate, and maintain testing equipment, maintain supplies, lab cleanliness and analytical instrumentation, as required.
Identify, troubleshoot and resolve technical issues.
Maintains up to date knowledge of current regulations / industry standards and products to be tested.
Assists in developing materials for and conducting client visits and educational tours.
Prepares quotes with client services, assisting with identifying appropriate standards / protocols for testing, providing direction and assumptions.
Other duties as defined by Manager, department needs and workload.
Report Preparation
Prepares written technical reports and directly works with CB and NRTL reviewers.
Perform final review and interpret data / reports, providing direction, as required.
Organizes and monitors workload to meet or exceed laboratory turnaround time and client expectations.
Assist in the coordination of technical & administrative aspects of various departmental projects.
Provides technical consultation to internal and external clients.
Research and development of new testing services / methods / procedures / set-ups, in a limited capacity with direction from senior staff.
Administrative
Organizes and monitors workload to meet or exceed laboratory turnaround time and client expectations.
Assist in the coordination of technical & administrative aspects of various departmental projects.
Technical Services
Provides technical consultation to internal and external clients.
Research and development of new testing services / methods / procedures / set-ups, in a limited capacity with direction from senior staff.
Calibrate, operate, and maintain testing equipment, maintain supplies, lab cleanliness and analytical instrumentation, as required.
Identify, troubleshoot and resolve technical issues.
Maintains up to date knowledge of current regulations / industry standards and products to be tested.
Make recommendations to clients for testing and inspections in a limited scope.
Assists in developing materials for and conducting client visits and educational tours.
Prepares quotes with client services, assisting with identifying appropriate standards / protocols for testing, providing direction.
Other duties as defined by Manager, department needs and workload.
Quality
Adhere to the requirements of the BV-CPS Quality System and assist with the implementation and maintenance of the Laboratory Quality System.
Provide feedback to department Manager regarding departmental systems, processes and recommendations for improvements.
Represent the Product Safety Department during certification audits.
Leadership
Provide technical support to Engineers / Technicians / External Clients.
Provide technical training to internal staff.
Additional Responsibilities for Engineer II :
Write, train, implement and update lab procedures, test protocols, and technical procedures.
Provide technical opinions / recommendations / interpretations pertaining to compliance, requests, testing issues to clients or client services.
Prepares verbal and written communication to internal and external clients, regarding administrative and technical issues.
Other duties as required.
Knowledge, Skills, Abilities
Method development skills
Strong written and verbal communications skills including the ability to communicate effectively in a group setting, with colleagues and clients
Organizational and time management skills
Ability to perform multiple tasks
Ability to organize and prioritize workload to meet or exceed deadlines
Individual and Team work ethic
Proficiency with Windows, Word & Excel
Attention to detail
Technical problem solving and process improvement skills
Solid working knowledge of UL, EN, IEC and other regulations and standards relating to Medical (60601, 80601 series) products and other related standards.
Knowledge of statistical analysis tools a plus
Strong technical and mechanical aptitude
Direct experience testing to Laser, High Frequency Surgical Equipment, ECG, or Imaging (X-ray, MRI) standards is a plus.
Experience and Educational Background Required for the Job
Bachelor’s degree in electrical engineering or biomedical engineering or similar field required.
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