suca2024
January 8th, 2008, 11:06 PM
Good Afternoon,
I was hoping you maybe able to assist me I need a Senior Failure Analysis Engineer to work with me in Sydney Australia, visa's can be arranged for the successful candidate.
You would need to:
· Perform analysis on returned devices, including explanted devices and product used in stressed environmental conditions. Perform verification and characterization of failures and defects in order to establish modes of failure, mechanism of failures and root cause of failures.
· Conducts improvement, development and implementation of methodologies and procedures for failure analysis of returned devices.
· Communicate failure analysis results to relevant departments.
· Provide technical input and support to the cross functional teams as required.
· Work closely with design development, manufacturing and quality assurance and with regional clinical and regulatory to provide product quality and reliability information and analysis to help in the resolution of complaints, regulatory reporting and implementation of corrective and preventive actions.
· Investigate and gather background information to establish the reason(s) for the explants or return of the device.
· Perform and/or provide technical direction in the actual testing and analysis of the returned device/s to verify failure, isolate the faults and establish the root cause(s)
· Analyse and determine the specific failure modes and mechanisms of returned devices.
· Characterize and establish those failure modes’ signature profiles.
· Write failure analysis reports and present findings to the designated complaints handling unit to ensure that the investigation and analysis were properly performed and verify the accuracy and validity of conclusion.
· Present information on product quality and reliability to other business groups to improve both the design and manufacture of devices ( e.g. provide input to reliability engineering activities such as Failure Modes Effects and Criticality Analysis (FMECA) studies.)
· Identify opportunities and implement improvements in the failure analysis procedures by reviewing and developing current/ new test systems, and methodologies.
· Identify and establish relationships with external testing and failure analysis laboratories capable of providing relevant specialized testing services.
· Coach and train other members of the team to facilitate learning and cross specialization within the team
You would need to have:
· Through knowledge of quality management system regulations for medical devices
· Bachelors Degree in Electrical/ Mechanical Engineering or Material Science
· Knowledgeable with electromechanical design principles. Digital and analog circuit analysis and design background (desirable for electrical engineering applicants).
· Strong background in failure analysis or product testing.
· Strong background in statistical analysis, reliability testing and strong problem solving skills.
· Able to work independently with minimal supervision.
· Ability to communicate effectively (written and verbal) at all levels of the Organization
If you are interetsed or know someone suitable please forward their email address or contact me and I will discuss the role further.
My email address is susan@joefitzpatrick.com.au
Thanks and best regards,
Susan.
I was hoping you maybe able to assist me I need a Senior Failure Analysis Engineer to work with me in Sydney Australia, visa's can be arranged for the successful candidate.
You would need to:
· Perform analysis on returned devices, including explanted devices and product used in stressed environmental conditions. Perform verification and characterization of failures and defects in order to establish modes of failure, mechanism of failures and root cause of failures.
· Conducts improvement, development and implementation of methodologies and procedures for failure analysis of returned devices.
· Communicate failure analysis results to relevant departments.
· Provide technical input and support to the cross functional teams as required.
· Work closely with design development, manufacturing and quality assurance and with regional clinical and regulatory to provide product quality and reliability information and analysis to help in the resolution of complaints, regulatory reporting and implementation of corrective and preventive actions.
· Investigate and gather background information to establish the reason(s) for the explants or return of the device.
· Perform and/or provide technical direction in the actual testing and analysis of the returned device/s to verify failure, isolate the faults and establish the root cause(s)
· Analyse and determine the specific failure modes and mechanisms of returned devices.
· Characterize and establish those failure modes’ signature profiles.
· Write failure analysis reports and present findings to the designated complaints handling unit to ensure that the investigation and analysis were properly performed and verify the accuracy and validity of conclusion.
· Present information on product quality and reliability to other business groups to improve both the design and manufacture of devices ( e.g. provide input to reliability engineering activities such as Failure Modes Effects and Criticality Analysis (FMECA) studies.)
· Identify opportunities and implement improvements in the failure analysis procedures by reviewing and developing current/ new test systems, and methodologies.
· Identify and establish relationships with external testing and failure analysis laboratories capable of providing relevant specialized testing services.
· Coach and train other members of the team to facilitate learning and cross specialization within the team
You would need to have:
· Through knowledge of quality management system regulations for medical devices
· Bachelors Degree in Electrical/ Mechanical Engineering or Material Science
· Knowledgeable with electromechanical design principles. Digital and analog circuit analysis and design background (desirable for electrical engineering applicants).
· Strong background in failure analysis or product testing.
· Strong background in statistical analysis, reliability testing and strong problem solving skills.
· Able to work independently with minimal supervision.
· Ability to communicate effectively (written and verbal) at all levels of the Organization
If you are interetsed or know someone suitable please forward their email address or contact me and I will discuss the role further.
My email address is susan@joefitzpatrick.com.au
Thanks and best regards,
Susan.