Genalyte, Inc.
Systems Integration Director/Sr Director
Genalyte, Inc., San Diego, California, United States, 92189
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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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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