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Danaher Corporation Failure Investigation Scientist in Newark, California

POSITION SUMMARY:

Each failure investigation team consists of approximately 3-7 individuals focused on diagnosing and resolving technical issues and providing technical recommendations. Issues may arise from both internal and external customers, including, but not limited to, production, customer complaints, and development. Teams typically focus on medium and high complexity issues for resolution requiring a quick turnaround time. The teams also provide key feedback to development organizations on guidelines for quality and reliability expectations.

We are looking for someone who is curious, observant, and is dedicated to continuous learning in a fast-paced environment. The associate will lead and coordinate medium to large scale investigations with guidance from senior associates and management. In addition, the associate will develop expertise in risk and impact assessment and provide guidance to development and implementation teams on technical requirements and project direction. This role will develop a nuanced technical understanding of the integration of Cepheid products.

ESSENTIAL JOB 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

  • Evaluate and develop potential mitigations and corrective actions

  • Work with cross-functional teams to implement corrective actions

  • Drive systemic investigations and continuous improvement projects to completion

  • Apply rigorous statistics methodology to guide investigations and corrective actions

TRAINING RESPONSIBILITIES:

  • Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience (in years):

  • Bachelor’s degree with 2+ years of related work experience OR

  • Master’s degree in field with 0-2 years of related work experience.

Knowledge and skills:

  • Experience with root cause analyses

  • Understanding of PCR

  • Learn through on-the-job training

  • Experience with complex data analysis

  • Statistics experience, including power levels, t-test, variance, and sampling plans

  • Ability to work independently and cross-functionally

  • Excellent organizational and communication skills (oral and written)

  • Excellent writing and documentation skills

  • Experience working in a laboratory

Physical requirements/abilities:

  • Pipetting

  • Sitting or standing at a lab bench

  • Operation of machinery

  • Occasional lifting

Other:

  • This role requires the associate is hands-on in the laboratory, including the use of hazardous chemicals and clinical specimens.

PREFERRED REQUIREMENTS:

  • Understand molecular biology products or molecular diagnostic product utilizing nucleic acid amplification tests including system level relationship between reagents, consumable, and instrument components

  • Experience with real-time multiplex PCR and/or working with and running Cepheid products

  • Experience with design of experiments (DoE)

  • Experience working in a biology lab environment with clinical specimens

  • Experience in clean room or biosafety environment with controlled gowning procedures

  • Experience working in a regulated (ISO-13485) industry

  • Experience with MiniTab analysis software

  • Experience with Agile Product Lifecycle or similar PLM systems

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

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.

Operating Company: Cepheid

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