Biomedical Research Engineer

Roche • Carlsbad, CA

152d • $76,100 - $120,000

About 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.

Requirements

• BS degree in Biomedical Engineering, nanomaterials, mechanical engineering, applied physics, or biotechnology.
• 3-5 years of R&D or troubleshooting experience in a diagnostics or biotechnology company.
• Experience in in-vitro diagnostics consumables and instrumentation within an ISO 13485/GMP compliant environment.
• Knowledge of root cause analysis techniques applicable to mechanical parts and assemblies.
• Understanding of mechanics, rapid prototyping, thermodynamics, chemistry, microfluidics, and materials.
• Experience with PDM systems, specifically SolidWorks PDM, and modeling tools such as FEA and CFD.
• Familiarity with data acquisition and instrument control programming platforms, such as LabVIEW or MATLAB.

Nice To Haves

• Experience with design of experiments, data analysis, tolerance analysis techniques, microfluidics systems, and plastic assembly techniques such as ultrasonic and laser welding.
• Experience with multiplex PCR assay, handling BSL 2, and working with human specimens that are potentially infectious.

Responsibilities

• Contribute to the concept-to-market and sustaining engineering efforts of IVD consumables.
• Hands-on involvement in supporting existing and new products in the market.
• Troubleshooting and root cause analysis.
• Creating and maintaining input and output specifications.
• Conducting concept and feasibility activities, prototyping, testing, and facilitating the transfer to manufacturing.
• Supporting the development of metrology and fixtures to enhance robust product development.
• Participating in failure analyses, root cause investigations, and test method development.
• Identifying critical to quality attributes and developing test 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.
• Providing troubleshooting support for assay integration.
• Supporting large-scale data analysis in JMP, MATLab, or Python.
• Supporting fixture design and optimization via CAD.

Benefits

• Discretionary annual bonus based on individual and Company performance.
• Comprehensive benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree