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Failure Investigation Scientist

  • Anywhere

Company :
Leica Biosystems

Location :
Sunnyvale, California

Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT

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Description :
PRIMARY RESPONSIBILITIES: Perform failure investigations elevated from or impacting the development process and/or clinical evaluation Analyze data to identify trends and areas for investigation Design and execute experiments as part of investigations Use product software and other software tools as part of testing Continuously document progress during investigations and prepare final reports Prototype and evaluate potential mitigations and corrective actions Work with cross-functional teams to implement corrective actions Drive systemic investigations and continuous improvement projects to completion, including implementation into R&D Apply rigorous statistics methodology to guide investigations and corrective actions MINIMUM QUALIFICATIONS Bachelor s degree or higher in biological or engineering related discipline Minimum of 2-4 years relevant professional experience Expertise in data analysis, design of experiments, and test automation including scripting, root cause analysis techniques and documentation of results Ability to work independently and cross-functionally to provide effective updates at executive level Ability to successfully lead multiple investigations simultaneously within short deadlines Excellent organizational and communication skills (oral and written) Excellent writing and documentation skills Experience with statistical analysis and data management Experience working in a manufacturing environment and/or within manufacturing operations under cGMP, ISO and FDA regulations. PREFERRED QUALIFICATIONS: Understanding molecular biology products or molecular diagnostic product utilizing nucleic acid amplification tests including system level relationship between reagents, consumable, and instrument components Experience with microfluidics Experience with automating data retrieval from text files, databases, and spreadsheets. Experience with MiniTab analysis software Experience in clean room or biosafety environment with controlled gowning procedures Experience working in a regulated (ISO-13485) industry Familiarity with real-time multiplex PCR Experience with Agile Product Lifecycle or similar PLM systems Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.