Systems Integration Director/Sr Director

ABOUT GENALYTE

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

WHY WORK FOR US

We believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and generous paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.

POSITION SUMMARY
The Systems Integration Director will lead the design, integration and test of IVD devices that drive seamless operation of Genalyte’s diagnostic platforms. This role will oversee (1) development of system level requirements, (2) the integration of hardware, software, and analytical components to ensure end-to-end performance, reliability, and scalability and (3) system level verification testing. This role will partner cross-functionally with Engineering, Assay Development, Quality, Program Management and Product Management to align technical solutions with business objectives and regulatory requirements. The ideal candidate is a strategic thinker with hands-on experience in complex systems integration, a passion for innovation, and a track record of leading high-performing technical teams.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to:

• Lead systems integration efforts across Genalyte’s diagnostic product portfolio, ensuring seamless hardware, software, and data interoperability
• Define and drive product architectures, integration strategies, and roadmaps to support new product introductions and existing system enhancements
• Collaborate with cross-functional teams to define system requirements, design specifications, and verification plans
• Oversee end-to-end system verification testing and ensure compliance with FDA and other regulatory standards
• Identify and mitigate technical risks throughout the system development lifecycle
• Interface with external partners, vendors, and key stakeholders to align integration solutions with strategic objectives
• Track and report key metrics for integration performance, project milestones, and system reliability
• Continuously assess emerging technologies to inform future integration strategies and product innovations

ADDITIONAL FUNCTIONS & RESPONSIBILITIES:

• Support the development of system documentation, design controls, and risk assessments
• Provide technical leadership and mentorship to team members, fostering professional growth and innovation
• Contribute to strategic planning and budgeting for technology development and system integration initiatives
• Represent Systems Integration in executive reviews, audits, and key stakeholder meetings

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• Minimum Bachelor’s degree in Systems Engineering, Electrical Engineering, Computer Engineering, or a related field; Master’s degree preferred
• 10+ years of experience in systems integration or complex product development within medical devices, diagnostics, or life sciences
• Proven experience leading cross-functional technical teams in a FDA regulated environment
• Strong understanding of software-hardware integration, embedded systems, and automation
• Exceptional problem-solving, analytical, and organizational skills
• Excellent communication skills with the ability to convey complex technical concepts to diverse audiences
• Demonstrated ability to manage multiple projects and priorities in a fast-paced, evolving environment
• Familiarity with design control processes, risk management and system validation best practices

  
  SALARY RANGE:

  The base range for this role is $180,000 - $220,000 per year. Individual pay may vary based on additional factors, including but not limited to, job-related skills, experience, work location, and relevant education or training. In addition to base salary, Genalyte provides generous benefits, equity opportunities, and for some roles, participation in our annual target bonus plan.

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