Systems Engineer – Quality and Testing
Celsee, Inc., is harnessing the gentle power of gravity to break down barriers in single-cell analysis. The Genesis System’s unparalleled capture and viability rates enable scientists to analyze molecular signatures from hundreds to millions of cells, uniquely allowing the process of two Slide Technologies for improved results across applications such as single-cell cytometry, single-cell proteogenomics, single-cell transcriptomics, rare-cell enumeration, and immune monitoring. This groundbreaking technology can achieve accurate biological insight by capturing more cells and provides a practical, scalable, and efficient approach to analyze rare cells. It is open and customizable to support method and application development as well as protocol optimization. Why choose to work at Celsee? Because Every Team Member Matters.
Celsee is seeking an experienced individual to join our innovative Systems Engineering team. In this cross-functional role, you will participate in product development and transfer activities for complex system and instruments. You will ensure product and process conformance to applicable safety and quality regulations and standards. You will be responsible for guiding teams in the execution of design control activities with a focus on new product development quality planning and risk management to positively impact the safety and efficacy of products.
Additionally, you will work in teams identifying, documenting assessing, correcting and preventing quality issues using risk analysis, root cause analysis tools, DFSS concepts from initial product concept through transfer to sustaining.
❯ Lead quality initiatives aligned on new product development teams, with a focus on systems and instruments
❯ Facility process in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development
❯ Aid in the assessment and qualification of raw materials, including development of component specifications and inspection standards
❯ Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
❯ Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions during transfer activities
❯ Ensure product development and validation programs meet requirements when applicable
❯ Analyze and report on quality data in order to improve product and process; develop recommendations based on data analysis
❯ Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
Position reports to the Director of Engineering and works on all assigned tasks/projects that are within scope for the defined position.
Most work is performed in an indoor office, engineering lab, and biochemistry wet lab environment. Minimal travel to local suppliers or consultants is required.
Occasional lifting of up to 50 pounds.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
*Celsee, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.