Intuitive
Healthcare
FailureAnalysisEngineer
“Failure Analysis Engineer at Intuitive. Skills: Failure analysis, Troubleshooting, 8D problem solving, Engineering drawings. Perform failure analysis. Assess existing failures”
What You'll Achieve.
improving patient value; improving product quality; driving reliability; driving quality; driving safety
Industry & Context.
Troubleshooting mind set; analytic skills; analyzing complex problems; solve challenging problems
What They're Looking For.
Must Have
A minimum of 4 years of experience in medical devices, engineering, or failure analysis., Troubleshooting mind set - an ability to methodically break down a system or process into subparts to identify failures and troubleshoot to a component level., Knowledge of 8D problem solving, Fishbone Diagraming, and the Five Whys., Proven ability to work in teams and to work cross-functionally., interpersonal and communication skills., Able to assist people in finding creative solutions around constraints., analytic skills as proven by track record for analyzing complex problems, technical report writing skills, Must be proficient in the use of Microsoft Office suite of applications., Able to verify assembly documentation accuracy and to read engineering drawings, Understanding of product risks and experience identifying improvements to FMEA and risk management documentation
Nice to Have
Knowledge of Good Manufacturing Practices & Quality Systems Regulations is a plus., Familiarity with SAP and Tableau is a plus., Familiarity with SQL and Snowflake is a plus., Knowledge of basic statistical analysis methods is desirable., Understanding of various advanced failure analysis tools/methodologies (ex: FTIR, SEM-EDS, fractography) is desirable.
What You'll Do.
Perform failure analysis
Assess existing failures
Assess potential failures
Document and disseminate how products fail
Ensure consistency of failure data
Analyze returned devices
Understand use conditions
Resolve reportable failures
Process returned devices
Track returned devices
Guide manufacturing teams
Assess failure trends
Assess failure statistics
Identify product improvements
Develop new failure codes
Provide guidance on recording results
Perform technical training
Create queries for data analysis
How You'll Work.
Team & Collaboration
Work with technicians; Work with FA engineers; Work with clinical engineers; Cross-functional collaboration; Interface with clinical engineering; Work with Post Market Surveillance team; Work with data analysis team; Work with Engineering; Work with Quality; Work with Regulatory groups; Work with Service Operations team
Communication Scope
interpersonal and communication skills; communicate technical answers
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