Job ID: CEP000706
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.
- Apply knowledge of relevant continuous improvement tools and approaches to increase production up-time, minimize unplanned maintenance, minimize work in process inventories (WIP) or plant inventories, and implement cost reduction initiatives across equipment and labor
- Assist in creating and updating manufacturing SOPs/Work Instructions.
- Provide training to Manufacturing personnel
- Seek and implement process improvements within Manufacturing
- Recognize machine operating conditions and requirements for optimum production runs and can troubleshoot and resolve basic line performance issues
- Identify constraints in, or non-conformances resulting from, the production process through analysis of material, people and information movement/flow
- Understand product cost drivers by interpreting product bill of materials and cost sheets to ensure adherence to projected cost
- Leverage knowledge of product costs and drivers and Design to Value concepts to effectively participate in cross-functional teams pursuing product cost improvement initiatives
- Effectively interface with other engineering disciplines, such as Controls & Automation engineering and New Product Introduction teams
- Develop and deliver oral and written communications around process improvement projects
- Organize an analytical approach to problem solving with familiarity with FDA and GMP
- Understanding of financial processes (standard cost development) and business planning
- In depth understanding of production and quality control techniques (such as CFM and TQM)
- Bachelor’s degree in Engineering or a related discipline; or equivalent combination of education and experience to perform at this level.
- A minimum of 6+ years overall related engineering experience within medical device or a regulated industry.
- Strong analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems
- Experience with failure investigations, root cause failure analysis, process engineering, etc.
- Fluent in the use of MS Excel for data analysis and presentation in graphic formats
- Solid mathematical skills with basic statistics knowledge
- Working knowledge of design of experiments and interpretation of test results
- Excellent communication skills. Must be able to communicate verbally in an efficient and effective manner and be proficient in document preparation and editing, including detailed test planning and report writing. Must be able to reduce data to coherent form for clear presentation.
- Must have ability to meet deadlines on multiple concurrent projects
- Must have demonstrated ability to communicate and coordinate efficiently across multiple functions and employee levels
- Self-directed requiring minimum supervision