If you are ready for a new and exciting challenge, we have an opportunity for an Engineer, Diagnostic Consumables. In this position, you will: Coordinate and drive new and existing consumable part and process qualifications from inception through completion; Design and execute validation and qualification test plans in accordance with FDA and ISO guidelines; Determine and execute the most appropriate testing to address process and system level performance issues involving cartridge consumables; Develop and validate consumables test methods and prepare test reports while adhering to Quality System and design control requirements; Perform failure analysis on Cepheid custom injection molded parts; Consult with engineers and other staff members to evaluate and improve the interface between consumables, manufacturing processes, and diagnostic platform.
This position entails a high level of organization, excellent communication skills, and rigorous process discipline and documentation to assure functionality, safety, reliability and quality of the product. The position frequently requires coordination of multiple simultaneous qualification activities, and the successful candidate will be comfortable multitasking and meeting concurrent deadlines.
Areas of job focus will include:
- Diagnostic Consumables Tooling Qualifications
- Materials Processing Failure Analysis
- Test Method Development and Validation
- Data Analysis
- Design and Process Verification Test Planning and Execution
- Compliance with Quality System requirements
- Bachelor's degree in materials science, mechanical engineering, bioengineering, or a related area
- 3 - 5 years of experience in a similar role.
- Advanced degree(s) may be considered as experience-equivalent.
- Demonstrated experience designing, coordinating, executing, and documenting complex product and/or process validations
- Must be fluent in the use of MS Excel for data analysis and presentation in graphic formats
- Solid mathematical skills.
- Basic statistics knowledge required
- Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes and policies
- 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.
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