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Senior Medical Product Safety Engineer - Milpitas, CA

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Date: Nov 24, 2021

Location: Milpitas, California, US

Company: Bureau Veritas

Position Summary

Develop and maintain productive client relationship through professional services by applying safety standards and regulations to various consumer products for a major client.  Protect the client's brand by actively participating in developing, implementing and measuring continuous improvement to the client's safety process.

 

Objective

Provide proactive assistance to clients by identifying and resolving Medical Product Safety issues, along with providing timely and accurate test reports and information to both internal and external clients that meet or exceed their expectations.

 

Major Roles & Responsibilities

Sample Preparation

  • Understand and interpret Medical Product Safety standard IEC60601-1 with some knowledge of the collateral and particular standards. 
  • Ability to perform testing according to IEC 60601-1.
  • Understanding of ISO 14971 Risk management Process.
  • Understanding of IEC 60601-1-6 and IEC 62366 Usability Engineering Process
  • Evaluate products submitted for Medical Product Safety testing..
  • Prepare a variety of samples for testing using prescribed testing methods, following testing standards / specifications.
  • 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 evaluate test results assisting clients.
  • Train employees on sample preparation method and test methods.
  • Assist with department testing in other areas, providing direction, as required.

Report Preparation

  • Prepares written technical reports.
  • Perform final review and interpret data / reports, providing direction, as required. 

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.
  • Maintain test equipment, 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 III:

  • 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.
  • Prepares quotes with client services, assisting with identifying appropriate standards / protocols for testing, providing direction.
  • Interface with staff members internally and at other locations on interpretations and to ensure global consistency with direction from senior staff.
  • Reviews written technical reports.

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) products
  • Knowledge of statistical analysis tools a plus
  • Strong technical and mechanical aptitude
  • Direct experience testing Laser,  Office and Measurement products Laser Safety testing experience a plus.

 

Experience and Educational Background Required for the Job

  • Bachelors degree in chemical engineering field required
  • 6+ years’ experience in Medical Product Safety