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The Position

GenMark, a member of the Roche Group, is dedicated to providing world-class solutions for multiplex testing, with enhanced features that contribute to Roche’s commitment to helping diagnose infectious diseases and reduce antibiotic resistance. As the world’s #1 diagnostics provider, the Roche Group offers an unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.

This position is fully on-site, based in La Place Ct, Carlsbad, CA.

The Opportunity

As a Research Associate in R&D Engineering, you will contribute to the concept-to-market and sustaining engineering efforts of IVD consumables. Your role includes hands-on involvement in supporting existing and new products in the market, troubleshooting and root cause analysis, creating and maintaining input and output specifications, as well as conducting concept and feasibility activities, prototyping, testing, and facilitating the transfer to manufacturing. These responsibilities will drive the success of IVD consumables efforts.

Also, in this role, you are:

• Supporting the development of metrology and fixtures to enhance robust product development.
• Participating in failure analyses, root cause investigations, and test method development.
• Participating in the identification of critical to quality attributes and the development of test specifications to ensure parts and assemblies can be reliably produced against material specifications. Testing and characterizing material and/or coating mechanical, electrical, and fluidic properties of cartridges and injection molded parts.
• Performing and documenting feasibility, design, verification, validation, and risk analysis activities under design controls.
• Performing experiments on manufacturing line equipment in a cleanroom environment, as well as experiments in R&D laboratory environments that may include BSL2 labs, prePCR, PostPCR, and engineering labs.
• Providing troubleshooting support for assay integration.
• Supporting large-scale data analysis in JMP, MATLab, or Python.
• Supporting fixture design and optimization via CAD (Computer Aided Design).

Who You Are

• You hold a BS degree and bring 2+ years of R&D or troubleshooting experience in Biomedical engineering, nanomaterials, mechanical engineering, applied physics, mechanical engineering or biotechnology, preferably including experience in a diagnostics or biotechnology company. 

Preferred behaviors, competencies, and qualities of the ideal applicant.

• Some experience in in-vitro diagnostics consumables and instrumentation working within an ISO 13485/GMP compliant environment

• Root cause analysis techniques, applicable in mechanical parts and assemblies.

• Knowledge in the principles of mechanics, rapid prototyping, thermodynamics, chemistry, microfluidics, and materials. 

• Experience with PDM systems, specifically SolidWorks PDM, and modeling tools such as FEA and CFD is desirable. Experience in data acquisition and instrument control programming platforms, such as LabVIEW or MATLAB, is also desirable.

• Experience with design of experiments, data analysis, tolerance analysis techniques, microfluidics systems, and plastic assembly techniques such as ultrasonic and laser welding is a plus.

• Experience with multiplex PCR assay, handling BSL 2, and working with human specimens that are potentially infectious is a plus.

• Consistent delivery of timely, accurate and thorough work product.

The expected salary range for this position based on Carlsbad, CA is $57,900 - $82,700.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits