Sr Staff Systems Engineer

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The Position

We advance science so that we all have more time with the people we love.

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 Sr. Staff Systems Engineer will drive systems engineering practices in projects, including defining requirements, designing system architectures, and implementing solutions to meet IVD standards. This individual will take ownership of project deliverables and facilitate the decision-making process with well-considered tradeoffs. 

• You have a comprehensive understanding of the system lifecycle process and can apply broad knowledge and skill-sets from the field of Systems Engineering to the organization.

• You can research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for differentiation and creative ideas for innovation.

• You will work closely with cross-functional teams, including R&D, Marketing, Operations, Quality, and Regulatory to ensure alignment with organizational objectives and regulatory requirements.

• You will engage with business leaders and Voice of Customer (VoC) representatives to ensure that technical solutions align with customer needs and market demands; facilitating stakeholder discussions to prioritize features and enhancements.

• You will analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address technical hurdles.

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This position is based in Carlsbad, CA.

Relocation benefits are not available for this position. 

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Who You Are:
(Required)

• You have a Bachelor’s in Engineering, Biomedical Sciences, or a related technical field with 8+ years of experience in systems engineering or related roles within the in-vitro diagnostics or medical device industry

• You have demonstrated knowledge of systems engineering principles, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation

• You have a scientific background and assay development experience.

• You have demonstrated a strategic mindset: showing the interest in innovative technologies and understanding of the competitive landscape in IVD.

• You have experience working in a regulated environment: demonstrating familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products.
   

Preferred:

• You have a deep knowledge in a specialty engineering skills like design for reliability, manufacturability, or usability.

• You have the experience to build authority and accountability within a team, with strong collaboration and communication skills.

• 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 c