Contract Engineer Jobs in Fallbrook, CA (NOW HIRING)

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.

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.

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.

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.

• 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.

Minimal; occasional travel to meet with contract engineering partners, (<10%).

This is a primarily office-based role in San Diego, CA. Occasional visits to laboratory and engineering environments may be required.

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).

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.