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Failure Investigation Engineer in Sunnyvale, California at Cepheid

Date Posted: 12/4/2018

Job Snapshot

Job Description

Job ID: CEP002543

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

JOB SUMMARY:

The Failure Investigation Engineer will perform and document investigations to determine root causes of various product failures. They will combine knowledge of real-time PCR, fluidics, and a technical understanding of the fully integrated Cepheid system to play a key role in root cause analysis during product development. They will evaluate and drive corrective actions to guide continuous product/process improvement through rigorous statistical analysis.

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

Job Requirements



Qualifications

MINIMUM QUALIFICATIONS
• Bachelor’s degree or higher in biological or engineering related discipline
• Minimum of 2 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 Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.