Director of Software Engineering, R&D

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

The Director of Software Engineering is responsible for all software development, verification, and validation efforts for GenMark's In Vitro Diagnostic (IVD) systems and assay panels. This role involves a strategic focus on driving software strategy, ensuring product quality, and fostering a culture of innovation. The Director is responsible for maintaining compliance with FDA guidelines and applicable internal and external standards, implementing robust cybersecurity measures, and developing the team to achieve departmental goals and drive excellence.

The Opportunity

• You will manage staff; provide staff with coaching, training and opportunities to develop skills, and give ongoing, constructive and timely feedback on performance and progress toward goals and expectations.

• You will provide vision, expertise, and leadership required for strategic software architectural direction.

• You will oversee design, development, and maintenance of software for IVD platforms and assays using Agile methodologies; you will ensure adherence to best practices in coding, testing, and deployment, and maintaining high standards of software quality.

• You will develop scalable, reliable, and secure software architecture.

• You will lead software test activities to ensure the product(s) meets regulatory and quality standards.; you will implement best practices in software V&V; you will develop and maintain V&V documentation for regulatory submissions.

• You will develop and implement robust cybersecurity measures to protect sensitive health data; you will ensure compliance with security and data privacy standards for medical devices throughout the software development lifecycle.

• You will collaborate with stakeholders to define product requirements and ensure that software solutions meet those requirements; you will effectively manage project timelines, resources, and budgets.

Who You Are:
(Required)

• You have a Bachelor's in Computer Science, Software Engineering, or a related field; or a Master's degree in Computer Science, Software Engineering, or a related field; You have 15+ years experience in software development, including 7+ years of direct experience in software management.

• You have experience leading teams in developing and validating software for FDA-regulated medical devices and IVD systems, with a track record of successful FDA-clearances.

• You have demonstrated experience in .NET Framework, with Hardware Integration, middle-tier and GUI development for medical devices; experience with hardware interfaces such as Ethernet, USB, etc. and related testing/debugging tools; demonstrated proficiency in communication protocol development for TCP/IP and USB using C# or C++.

• You will effectively review, analyze, and debug technical problems including at hardware/software interface; you have a high level of proficiency and understanding of software V&V methodologies and FDA guidelines for software development, cybersecurity, and data privacy for IVD systems

• You have demonstrated experience with localization and translations; experience with medical device connectivity including bidirectional LIS protocols (ASTM, HL7)

Preferred:

• You have experience with Agile methodologies, CI/CD, TDD, and DevOps.

• You have the ability to complete work in a timely, accurate and thorough manner; you are able to think and work both tactically and strategically; you are hands-on, self-directed, and organized.

• You have demonstrated communication skills including the ability to communicate with multiple levels within the organization; you have strong presentation and influence skills.

• You have strong time management and organizational skills in a dynamic, constantly changing environment; you have the ability to respond effectively to sensitive inquiries, as well as communicate effectively both orally and in writing with management, peers and individuals.

• You have strong project management skills

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 on-site in Carlsbad, CA. The ability to travel between sites (Torrey Pines, CA) is required.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of Carlsbad, CA is $160,000 - $298,000. 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

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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.