STAFF SYSTEMS INTEGRATION ENGINEER-LAB AND MOLECULAR DX
Siemens Healthcare Diagnostics Inc.

Company: Siemens Healthcare Diagnostics, Inc.

Location: GBC Drive, Suite 500, Newark, DE 19702

Position Title: Staff Systems Integration Engineer - Lab and Molecular DX

Hours: Monday - Friday, 8:00 am to 5:00 pm, 40 Hours/ Week

Summary of Duties: Responsible for leading the assay and instrument integration activities in new product development and installed fleet support for laboratory and molecular diagnostics product lines. Drive the development of Laboratory Diagnostics products from concept, design, characterization studies, integration approach, and verification strategy for next generation diagnostics products (clinical chemistry, immunoassay, molecular, and hematology systems). Interface with the R&D Assay development organizations for the various new product development projects and installed fleet support. Oversee, plan, and execute experiments to design feasibility, and identify and characterize critical design parameters and their boundaries that influence assay performance. Provide systems technical guidance and knowledge transfer to internal fleet support and service teams when instrument and assay performance issues arise at critical customer sites. Analyze system and assay performance test data and establish acceptance criteria. Write and review data-driven technical summaries and test reports and lead technical reviews. Ensure compliance to all quality procedures and policies of product development. 15% domestic travel required.

Qualifications: The position requires a Master's degree in Pathology and Infectious Diseases, Biotechnology, Microbiology, Chemistry, Biochemistry, Biophysics, or a related field and five (5) years of experience in the job offered, or as a Systems Engineer, Biochemist, Biomedical Engineer, or a related occupation.

The position requires four (4) years of experience with the following skills: Experience in new product development and installed fleet products; Laboratory and molecular diagnostic commercial product experience; Experience with laboratory, diagnostics assays and lab practices; Experience implementing and troubleshooting IVD assays on a high throughput; Experience with Design of Experiments and Biostatistics; Experience with FDA and international quality system regulations and processes; Experience with electro-mechanical, chemical, biochemical, software, or mathematical, process operations in diagnostics systems; Experience with Agile and Scrum within the development environment of hardware-software integrated products. 15% domestic travel required.

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