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Roche is the world’s #1 provider of companion diagnostics, offering unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.
The Senior Software Engineer (Engineer) will design, develop, and maintain software for medical devices with the R&D and Manufacturing teams, ensuring compliance with regulatory standards (e.g., FDA, ISO, IEC). The Engineer will collaborate with cross-functional teams, including hardware engineers, quality assurance, and clinical experts, to define software and hardware requirements and specifications. In addition, the Engineer will be expected to troubleshoot and resolve complex software/hardware issues to closure in a timely manner, providing technical support during product development and post-market phases.
You will demonstrate a familiarity with hardware interfaces such as Ethernet, USB, etc. and related testing/debugging tools
You will lead and mentor junior software engineers, fostering a culture of innovation, collaboration, and continuous improvement.
You will conduct code reviews, technical design reviews, write unit tests, and participate in system testing to ensure high-quality deliverables; staying current with industry trends, technologies, and regulatory requirements to ensure our software solutions remain cutting-edge.
You have the ability to work effectively in a fast-paced, team-oriented environment.
You will contribute to the creation and maintenance of technical documentation, including design specifications, risk analysis, and user manuals.
Who You Are:
(Required)
You have a Bachelor’s in computer science or computer engineering with 8+ years of experience in software development along with 3+ years in the medical device or healthcare industry ; or a master’s degree in computer science or computer engineering with 6+ years of experience in software development along with 3+ years in the medical device or healthcare industry .
You have demonstrated ability in communication protocol development for TCP/IP and USB using C# or C++.
You have demonstrated experience in .NET Framework, with Hardware Integration, middle-tier and GUI development (WPF, WinForms, XAML); you excel in Software/Hardware problem-solving/debugging capabilities
You have a strong understanding of software development life cycle (SDLC) and Agile methodologies.
Preferred:
You have strong verbal and written communication skills, with the ability to convey complex technical concepts to non-technical stakeholders.
You have experience with version control systems (e.g., Git), continuous integration/continuous deployment (CI/CD) pipelines, and automated testing frameworks.
You have experience with cybersecurity practices in medical device software development.
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 $107,200 - $199,200. 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.
#genmark2025
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.
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