Staff Electrical Risk Management Engineer

Abbott Vascular
Temecula, California
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

    

Contribute to resolving significant technical issues and to the development of company objectives. Works independently (or in a lead role) on the design and development of critical electrical designs for medical device using IEC60601 Standards.  Works independently on identifying new technologies for implementation into new product development both software and hardware.  Exercises independent judgment in identifying, recommending and implementing significant and/or complex new electrical design improvements to meet new product development and regulatory requirements. May lead technical teams in the accomplishment of electrical engineering activities. Develops networks involving cross functional/cross departmental groups as well as communication to Sr. Management.

 

MAJOR RESPONSIBILITIES

 

    • Responsible for implementing and maintaining the effectiveness of the quality system.
    • Develop, implement and maintain a risk management process in the Quality System that conforms with IEC60601 across product realization by providing strategic and tactical direction.
    • Maintain a sound, consistent, and sustainable approach to risk management.
    • Manage health and safety risk by identifying and communicating product safety risks at each phase of the product life cyle.
    • Create and maintain risk management records compliant with international standard ISO 14971 and Divisional procedures.
    • Define best practices to aid in the implementation of risk management requirements.
    • Provide guidance to product teams regarding risk identification, assessment, control, and communication
    • Specify, design, verify and validate new electrical designs, in accordance with applicable medical regulatory standards.
    • Responsible for the development of technical project plans and schedules covering all engineering activities (Meeting all Design control and process/product development SOP requirements)
    • Works in the development of significant product specifications, design FMEAs, DOEs, validation protocols.
    • Works in the creation of schedules and budgets.
    • Communicate effectively and participate on cross functional development teams.
    • Participate in technical design reviews for electrical designs and product design and requirements documents.
    • Write and submit Engineering Change Orders, as required.
    • Ensures that electrical designs and test equipment meet all applicable standards.
    • Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management

 

Preferred Skills:  Expertise with IEC60601

 

MINIUM EDUCATION

 

    • BS in an Engineering Discipline (Electrical or Physics preferred), or equivalent relevant experience. MS degree or PhD ideal.
    • 8 yrs. relevant experience.  Some experience in engineering management or technical leadership desirable.
    • Good knowledge of general Engineering principals
    • Solid knowledge of regulations for medical device development, (ISO134851, ISO13485, FDA)  
    • Excellent written and verbal communication skills are essential.
    • Extensive understanding of processes used in the design and manufacturing of medical devices, particularly handheld devices.

 

Experience in all the following:

 

    • Performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis working in a development environment with an emphasis on medical product development writing process/product requirements and design specifications.
    • Working on a development team with an emphasis on minimizing time to market.
    • Design for manufacture of low cost, high volume handheld electronic products.
    • Solid understanding of GxP, ISO and medical device regulations, particularly with respect to the development of new products/processes in the regulated environment.
    • Experience working in cross functional team environments is desired.
    • Strong technical experience in the Electrical Engineering or relevant discipline
    • Development and execution of new processes, equipment, materials, verification and validation
    • Implement approved Design Control procedures for process development in accordance with FDA guidelines.

 Use the link below to apply

https://www.jobs.abbott/us/en/job/30921477/Staff-Electrical-Risk-Management-Engineer

 

 

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Staff Electrical Risk Management Engineer

Abbott Vascular
Temecula, California

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