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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 provider of diagnostics, the Roche Group offers an unrivaled experience in developing and commercializing tests that enable personalized treatment strategies for patients. 

As a member of our R&D team, the Systems Engineer will assist in the development and implementation of systems engineering methodologies, including requirements gathering, system architecture design, and solution implementation under the guidance of senior engineers. 

You will participate in ensuring compliance with IVD standards through support roles in various projects and will provide an understanding of the system lifecycle process.

You will stay up-to-date with industry trends, emerging technologies, and systems engineering best practices’ learning and applying broad product knowledge to improve product functionality, including hardware, software, microfluidics, and assay integration.

You will work effectively within cross-functional teams including R&D, Marketing, Operations, Quality, and Regulatory; Ensuring clear and concise communication with team members and stakeholders to support project objectives and regulatory compliance.

You will assist / provide support to gather and analyze customer requirements to support the alignment of technical solutions with customer needs and market demands; participate in stakeholder meetings to help prioritize project features and enhancements.

You will support the identification and analysis of technical challenges; collaborate with team members to present multiple solution paths and provide detailed information to help stakeholders make informed decisions.
 

Who You Are:
(Required)

You have a Bachelor’s in Engineering, Biomedical Sciences, or a related technical field with 1+ years of relevant (academic, diagnostics) experience.

You have a demonstrated understanding of systems engineering principles, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation; along with a deep knowledge in a specialty engineering skill like design for reliability, manufacturability, or usability is preferred. 

You have demonstrated experience with an application/product lifecycle management software for connecting Systems Engineering outputs (e.g. DOORS, Hp ALM, Retina, etc.).

You have demonstrated the ability to take accountability for tasks and be proactive within a team, along with strong collaboration and communication skills.
 

Preferred:

You have a demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD.

You have a good level of familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products.

You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you have the ability to formulate and solve problems; you complete work in a timely, accurate and thorough manner

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate.  This position may involve a combination of office and biotechnology laboratory environments.   The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment. While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear.  The employee is frequently required to stand and walk.  The employee may sometimes be required to lift and/or move up to 35 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

This position is based in Carlsbad, CA.

Relocation benefits are not available for this position. 

The expected salary range for this position based on the primary location of Carlsbad, CA is $62,000 - $123,500.  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

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GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare.  As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses.  GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.