Failure Investigation Engineer

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 :

Determine impact of failures to different areas of the business

Communication of results and investigation progress to management

Provide recommendations for investigation direction and / or countermeasures

Continuously document progress during investigations and prepare final reports

Analyze data to identify trends and areas for investigation

Investigate failures through established root cause analysis techniques and methods, such as data analysis and physical inspection

Recommend and implement improvements to current workflows, procedures and techniques

Design, execute, and interpret single and double factor experiments

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 :

Understanding of PCR and Cepheid products

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 :

Bachelor’s degree or higher in biological or engineering related discipline

Experience with design of experiments (DoE)

Experience with test automation including scripting

Experience with root cause analysis techniques and documentation of results

Experience working in a biology lab environment with clinical specimens

Experience working in a manufacturing environment and / or within manufacturing operations under cGMP, ISO and FDA regulations

Experience working with and running Cepheid products

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.

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