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System Architect, Product Development Job (Raritan, NJ, US)

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Johnson & Johnson companies are equal opportunity employers.

System Architect, Product Development-4206140909

Description

Janssen Diagnositcs, LLC, a division of Johnson & Johnson's Family of Companies is recruiting for a System Architect, Product Development to be located in Raritan, NJ.

Janssen Diagnostics LLC’s goal is to innovate within personalized medicine by developing and commercializing diagnostics and health IT that support treatment decisions in our five major therapeutic areas (e.g. infectious diseases; oncology; neuroscience; cardiovascular and metabolism; and immunology).

The System Architect, Product Development is responsible for leading the system engineering and integration of medical diagnostic instrumentation that will support Janssen Diagnostics diagnostic assays. Working with technical leads, the System Architect, Product Development, will define the overall system architecture of this instrumentation platform supporting multiple assays and lead the transformation from concept to commercial release.

In conjunction with software, hardware engineers and scientists, the System Architect will be responsible for leading all phases of the instrument design process, including the definition of system requirements, process maps, architecture and interface specifications, critical to quality/performance parameters, design specifications, integration testing, risk identification and mitigation, and general oversight to make the system robust. Working with external partners, the System Architect will oversee designs for outsourced modules and components, and coordinate internal and external work streams to ensure integration of system components with software and assays. The incumbent will be responsible for evaluating design changes, generating and reviewing change control documents, standard operating procedures, and validation documents.

This individual will comply with Janssen Diagnostic's policies, procedures, and quality standards as well as safety and environmental regulations. The System Architect will supervise the activities of assigned personnel, including establishing priorities and work schedules.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer

Qualifications


A minimum of a Bachelor’s degree in Engineering or a related science is required. An advanced degree in Engineering or related science is desired.

Ten years of practical knowledge in In Vitro Diagnostics (IVD)system design is expected, with the demonstrated ability to take designs from concept to production. At least five years of experience in developing IVD systems incorporating automated instrumentation, complex disposables, and multiple reagents and assays is required. Experience working closely with software, hardware, and disposable engineers as well as assay and reagent development scientists will also be required.

Three or more years of experience in software development is desired. The candidate should have practical system engineering experience in an IVD environment and an understanding of clinical lab practices and the operating environment of our users (RUO and IVD). Solid experience working with internal and external partners to resolve technical issues is needed along with strong problem solving skills. A thorough knowledge of experimental design is expected. An ability to review technical and analytical data, extract and analyze relevant data, form data-driven conclusions and write reports will be required. This position requires thorough knowledge of domestic and international requirements.

Strong team and leadership skills, along with the ability to work independently, are expected. Previous people management experience is expected. Excellent written and oral communication with project management skills is required.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies

Primary Location:North America-United States-New Jersey-Raritan
Organization: Janssen Diagnostics, LLC (6139)
Job Function: R&D Engineering (R&D)

Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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