Failure Investigation Engineer, Bangalore
Role: Failure Investigation Engineer
Essential Job Responsibilities:
- Support manufacturing in first-line investigations of product or process failures.
- Drive failure investigations elevated from customer complaints, statistical process trending, or stability studies.
- Support improvement projects resulting from root cause investigations.
- Lead brainstorming and other root cause analysis techniques.
- Participate or lead PSPs (Problem Solving Processes).
- Design and execute experiments as part of investigations.
- Work with cross-functional teams to provide knowledge and support to NPI (New Product/Process Introduction) or Sustain and Support projects.
- Use product software and other software tools as part of testing.
- Develop new test methods and tools for failure investigation use.
- Continuously document progress during investigations and prepare final reports.
- Prototype and evaluate mitigations and corrective actions.
- Analyze historical data to identify abnormal trends.
- Perform failure trending and analysis on key performance metrics of various products and compile data for team review.
Completes all assigned and required training satisfactorily and on time.
- Education and Experience (in years):
- MSc in Molecular Biology or similar Life Sciences or MSc Biotechnology or minimum of 3 years equivalent work experience to perform at this level.
- Knowledge and skills:
- Proficiency in molecular biology and real time PCR.
- Experience in data analysis, product inspection, design of experiments, software engineering and automation including scripting, root cause analysis techniques, and documentation according to GMP.
- Knowledge of Cepheid’s products, manufacturing, and release processes.
- Ability to work independently and cross-functionally to provide effective updates at an executive level.
- Good skills in Excel.
- Excellent organizational skills.
- Excellent communications skills written, oral, and presentation.
- Experience with statistical analysis and data management for large volume complex datasets.
- Physical requirements/abilities:
- Ability to work in an office, laboratory, and production environment.
- Flexible to work in shifts and weekends.
- Experience in root cause analysis techniques.
- Working experience in a manufacturing environment.
- Working experience in a global environment.
- Working experience in a support organization.
- Experience in working in a regulated environment (ISO, GMP).