Principal Systems Engineer – Life Science Instrument Architecture

Sarmal, Inc. is an innovative biotech company based in San Diego, California developing revolutionary genomics platforms that aim to transform the fields of genetic testing and sequencing. We are seeking a Principal Systems Engineer to own and drive the systems-level architecture of our TEEM platform, which combines precision instruments, consumables, optical detection, and fluidics into an integrated molecular diagnostics system. This individual will work across all phases of the product development and launch lifecycle, ensuring that subsystem interfaces, performance requirements, and design trade-offs are well defined and rigorously managed from concept through commercial release.

Key Responsibilities:

• Define and maintain the overall system architecture for the TEEM platform, encompassing instrument hardware, consumables, optical detection, and fluidic subsystems.
• Develop system-level requirements, interface specifications, and performance budgets that flow down to subsystem and component teams.
• Drive systems integration activities, ensuring that instrument-consumable interactions perform reliably across manufacturing tolerances and use conditions.
• Own the system-level risk register and DFMEA, coordinating mitigation plans across engineering disciplines.
• Support all phases of the product development lifecycle including concept development, feasibility, design verification, design transfer, and product launch.
• Collaborate with Assay Development, Software, Manufacturing, and Quality teams to ensure system-level requirements are met and validated.
• Author and review system-level documentation including architecture documents, design history file contributions, and test protocols.
• Provide technical mentorship to cross-functional engineering teams and serve as a key technical authority on platform design decisions.

Qualifications:

• Deep experience with life science instrument architecture that combines instruments and consumables, with particular emphasis on optical detection and fluidic subsystems.
• Demonstrated experience developing a product through all phases of the product development and launch lifecycle, from concept through commercial release.
• Strong systems engineering fundamentals including requirements decomposition, interface control, tolerance analysis, and verification/validation planning.
• Experience working with and managing vendors / outsource design partners
• Experience in molecular diagnostics product development preferred.
• Knowledge of or experience with surface chemistry and sample preparation workflows preferred.
• Familiarity with IVD regulatory requirements (FDA 510(k), ISO 13485, IEC 62304) preferred.
• Direct experience operating under design controls is preferred.
• Excellent communication skills with the ability to convey complex technical concepts to diverse stakeholders.
• Strong cross-functional collaboration with engineering, assay, software, and operations teams.

Education:

• B.S., M.S., or Ph.D. in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Optical Engineering, Physics, or related field.
• Minimum experience of 12 years with B.S., 10 years with M.S., or 7 years with Ph.D.

Salary Range:

• $160,000-215,000