Staff Assay Integration Engineer / Panel Architect

Truvian Sciences•San Diego, CA

7d•$168,000 - $183,000•Onsite

About The Position

Truvian is a healthcare technology company focused on transforming blood testing through an innovative, automated benchtop diagnostic platform. This platform delivers laboratory-quality results quickly and affordably, making blood testing more accessible. The company has received FDA clearance and is pursuing CLIA Waiver status to further enable point-of-care testing. Truvian fosters a culture of discovery and empowerment, aiming to put health information into the hands of individuals and make routine health testing convenient, affordable, and actionable. This Staff Assay Integration Engineer / Panel Architect position is crucial as Truvian enters its next phase of evolution. The role serves as the technical architect responsible for translating individual assay requirements into an integrated, manufacturable, and scalable diagnostic panel. It bridges Assay Development, Consumables Development, Software, Instrument Engineering, Manufacturing, and Clinical Development. The ideal candidate will have a strong understanding of diagnostic assay development across multiple modalities and hands-on experience in cross-functional assay integration with software, hardware, manufacturing, and clinical development. The individual will own panel architecture and theory of operation, ensuring seamless integration of workflows from sample preparation to detection, and driving system-level decisions that impact assay performance, time-to-result, throughput, manufacturability, reliability, and menu expansion. This role offers a unique opportunity to deepen knowledge in clinical studies, data analysis, FDA submissions, and regulatory strategy, reporting to the VP Clinical and Assay Development.

Requirements

A bachelor’s degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Systems Engineering, Biochemistry, Bioengineering, or a related scientific or engineering discipline.
8+ years of relevant experience in IVD, medical device, or diagnostic instrumentation development, with direct experience across multiple technical streams on an instrument program (not limited to a single discipline).
Demonstrated experience developing or integrating scripts, sequencing logic, or workflow control for an automated diagnostic or laboratory instrument.
Working knowledge of microfluidics and reagent chemistry, including fluidic behavior, reagent stability, and chemistry timing constraints, sufficient to evaluate whether a script satisfies assay requirements.
Working knowledge of firmware/embedded interfaces, including how scripts communicate with low-level hardware controls, actuators, and sensors.
Proven ability to debug issues that span chemistry, hardware, and software domains, including full-system integration failures that do not reproduce in isolated unit or subsystem testing.
Experience contributing to V&V test planning and root cause investigations within a design-controlled environment.
Strong cross-functional communication skills, with the ability to translate technical findings between Assay, Panel, Software, and Algorithms teams.
Strong understanding of clinical chemistry, immunoassays, fluidics, consumables, instrumentation, and software-controlled workflows.
Experience with integrated diagnostic systems under FDA design controls.

Nice To Haves

A Master of Science (M.S.) or Ph.D. is strongly preferred.
Experience in a regulated environment, such as 510(k), CLIA waiver, ISO 13485, or equivalent design control frameworks.
Familiarity with risk management practices under ISO 14971.
Exposure to imaging-based or optical detection assay workflows.
Experience with configuration management and traceability tooling (for example, Azure DevOps, Jira, or similar ALM platforms).
Background in systems engineering or related discipline (biomedical, chemical, mechanical, or electrical engineering).

Responsibilities

Own overall panel architecture and theory of operation.
Define assay sequencing, timing, incubation strategies, and workflow optimization.
Translate assay chemistry and workflow requirements (sample prep, reagent handling, incubation, detection) into a script that correctly sequences the corresponding hardware actions (pipetting, heating, mixing, imaging).
Partner with the Assay stream to understand chemistry constraints, including reagent stability windows and reaction timing tolerances, and reflect those constraints accurately in script logic.
Partner with Panel/Hardware to understand mechanical and timing constraints (motion profiles, fluidic path limitations, thermal ramp rates) that bound feasible script design.
Partner with Software/Firmware to ensure the script executes reliably within the system architecture and real-time timing budgets.
Debug cross-domain issues where assay performance, hardware behavior, and software execution intersect, including cases where a step performs correctly in isolation but fails during full system integration.
Contribute to V&V test planning for script-related requirements, including defining acceptance criteria for sequencing, timing, and error handling.
Support root cause investigations tied to script logic or sequencing, and drive corrective actions through to closure.
Maintain script version control, configuration management, and traceability to the requirements it implements.
Communicate script-related risks and trade-offs clearly to Assay, Panel, Software, and Algorithms stakeholders, since script issues frequently require coordinated root cause analysis across streams.
Develop in-process assay QC strategies.
Design efficient utilization of instrument resources, fluidics, consumables, and software.
Evaluate impacts of adding new assays or panels to existing workflows.
Serve as the primary interface between Assay Development, Software, Engineering, Consumables Development, Manufacturing, and Clinical Development.
Drive integration decisions and resolve conflicts between subsystem requirements.
Establish system-level requirements for assay execution.
Optimize panel performance, throughput, and time-to-result.
Analyze interactions between assays and shared platform resources.
Lead root cause investigations involving integrated system performance.
Develop integration strategies for new immunoassays, clinical chemistry assays, and hematology workflows.
Identify platform constraints and recommend hardware, consumable, or software improvements.
Own panel configuration management and traceability.
Assess impact of assay, software, consumable, and instrument changes.
Support design reviews, risk assessments, verification, and validation activities.
Define integrated workflow test plans.
Develop system-level performance studies.
Support regulatory submissions and design control activities.