ABOUT GENALYTE
At Genalyte, we’re revolutionizing diagnostic testing to empower a healthier future. Genalyte is a San Diego-based diagnostics company developing the Merlin platform, a novel photonic ring resonator-based system designed to deliver rapid, multiplexed diagnostic results. 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
Joining Genalyte at this pivotal pre-commercial stage means your work will have real, visible impact — on our technology, our culture, and ultimately on how diagnostic testing is delivered to patients. Regardless of your role, you'll be part of a collaborative team working closely with leadership to build something meaningful from the ground up. Genalyte offers competitive compensation including base salary, significant equity participation, and a comprehensive benefits package. This is a rare opportunity to grow alongside a high-impact company at a genuinely exciting moment in its journey.
POSITION SUMMARY
The Manager/Staff Systems Engineer will independently apply systems design approaches to projects that have both life science/chemistry and software, instrumentation and engineering components. They lead activities to bridge between development teams and stakeholders to ensure a high quality product development lifecycle. Oversees system level performance product portfolios comprising software and instrumentation, through close collaboration with Lab Operations, software dev, hardware engineering, and other functional groups.
ESSENTIAL FUNCTIONS & RESPONSIBILITIES
These may include but are not limited to:
- Engage with cross-functional teams including hardware engineering, software engineering, assay development, and external contract engineers to drive system-level performance of Genalyte’s products.
- Work with cross-functional teams to establish and refine system level requirements.
- Provide product development leadership alongside product development managers to take products from concept to delivery while ensuring quality, extensibility and maintainability
- Create input/output relationships (interface definition) between key functional elements and identify constraints w.r.t manufacturability, cost, complexity and risk mitigation
- Lead efforts to create, curate and maintain well-formed requirements specifications for software, optics, electronics and embedded, and opto-mechanical sub-systems
- Key contributor to the system and sub-system level risk management activities with assigned programs
- Contribute to multiple cross-functional projects with an eye on overall system architecture and fulfillment of interface contracts between sub-systems
- Provides advice and consultation to engineering teams regarding system engineering principles and system level requirements
- Actively participates in decision making processes that involve changes to the system level design
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS & ABILITIES
- Prior experience in medical devices, diagnostics (IVD), or healthcare technology in a regulated environment required
- Master's or higher degree in Engineering including training and experience in systems, electronics, software and mechanical engineering
- 6+ years of experience leading the architecture and design of products spanning multiple engineering disciplines. At least 3+ years of experience leading and supporting software product development activities
- Product development experience in regulated/process driven environments is preferred
- Possesses a broad knowledge base with strong grasp of engineering principles preferably in life sciences instrumentation and apply this knowledge to address issues from technology development to concept development to product launch
- Ability to produce high-quality documentation and figures to describe complex systems concepts and architecture, requirements specifications and other process documents
- Excellent communication and interpersonal skills required
- Fluent in Python or an equivalent language for engineering problem solving
- Experience working with electrical, mechanical, optical, and chemical systems.
- Creative individual with strong analytical and problem solving
TRAVEL REQUIREMENTS
Minimal; occasional travel to meet with contract engineering partners, (<10%).
PHYSICAL REQUIREMENTS & WORK ENVIRONMENT
This is a primarily office-based role in San Diego, CA. Occasional visits to laboratory and engineering environments may be required.
COMPENSATION
The base salary range for this role is $150,000 - $175,000 per year. Individual pay may vary based on job-related skills, experience, and relevant education or training. In addition to base salary, this role includes meaningful equity participation, eligibility for the target bonus plan, and a comprehensive benefits package (health, dental, vision, and flexible time off policy).
EQUAL EMPLOYMENT OPPORTUNITY
Genalyte, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.
Skills Required
- Prior experience in medical devices, diagnostics, or healthcare technology in a regulated environment
- Master's or higher degree in Engineering including training in systems, electronics, software, and mechanical engineering
- 6+ years of experience leading the architecture and design of products across multiple engineering disciplines
- 3+ years of experience supporting software product development activities
- Ability to produce high-quality documentation and figures for complex systems
- Fluent in Python or an equivalent language for engineering problem solving
What We Do
Genalyte is a tech-enabled, full service CAP accredited and CLIA certified laboratory. We perform the majority of tests with our rapidly deployable mobile laboratory in under 30 minutes. Our central lab handles tests that cannot be performed onsite. All results are run through CloudLab, our proprietary tele-health platform, for quality oversight and monitoring by Clinical Lab Scientists. Core to our mobile capabilities is the Maverick platform, which has unprecedented serological testing functionality - permitting up to 64 simultaneous immunoassays on whole blood in 15 minutes. The platform achieved FDA clearance in Oct 2019. In these unprecedented times, we have developed a rapid COVID-19 serology test for IgG and IgM antibodies, while simultaneously including flu and other respiratory illnesses for differential diagnosis. For more information, visit www.genalyte.com.






