Staff Assay Integration Engineer / Panel Architect

ABOUT

Want to join a fast-paced, innovative company that is transforming the future of blood testing? Truvian is a healthcare technology company operating at the intersection of diagnostics and consumer technology. We have developed an automated benchtop diagnostic platform that delivers laboratory-quality results in 30 minutes or less across a broad range of health tests.

Our proprietary technology, which has received FDA clearance, is designed to make blood testing more accessible, convenient, and affordable by providing comprehensive results from a single small blood sample in minutes-whether in a retail setting or a private clinic. As we continue to expand access to diagnostic testing, we are actively pursuing CLIA Waiver status to further enable point-of-care testing and bring high-quality healthcare closer to where patients need it most.

To us, our work at Truvian is more than a job - It's a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today's connected consumers!

JOB SUMMARY

Truvian is seeking a Staff Assay Integration Engineer / Panel Architect as we enter the next phase of our evolution. This position is ONSITE.

The Staff Assay Integration Engineer serves as the technical architect responsible for translating individual assay requirements into an integrated, manufacturable, and scalable diagnostic panel. This role sits at the critical juncture between Assay Development, Consumables Development, Software, Instrument Engineering, Manufacturing, and Clinical Development. The successful candidate must possess working knowledge of diagnostic assay development in 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 that sequencing and integration of workflows between sample preparation, liquid handling, assay workflows, consumables, software, and instrument resources operate together to deliver robust analytical assay performance.

This position drives system-level decisions that impact assay performance, time-to-result, throughput, manufacturability, reliability, and menu expansion.

If you want to deepen your knowledge of clinical studies, data analysis, FDA submissions, and regulatory strategy-all while working alongside experienced mentors-this role is for you. This role will report to the VP Clinical and Assay Development.

HERE'S WHY YOU'LL LOVE THIS JOB:

• Unique Growth Opportunity: Gain hands-on experience across clinical studies, assay development, data analysis, regulatory submissions, and product development.
• Data-Driven Innovation: Work alongside experienced leaders, contributing to real-world healthcare solutions backed by rigorous data.
• Fast-Paced Start-Up Culture: Be part of an agile, mission-driven team where your work has immediate impact.
• Meaningful Impact: Help bring innovative diagnostic products to market that can improve patient outcomes.
• You love and thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape
• You'll have great perks such as:
• Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K),
• Flexible vacation
• Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks
• Onsite gym
• Farm to table onsite restaurant including a 30% discount

WHAT YOU WILL DO:

Panel Architecture

• 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.

Cross-Functional Integration

• Serve as the primary interface between:
• Assay Development
• Software
• Engineering
• Consumables Development
• Manufacturing
• Clinical Development
• Drive integration decisions and resolve conflicts between subsystem requirements.

System Performance

• 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.

Menu Expansion

• Develop integration strategies for new immunoassays, clinical chemistry assays, and hematology workflows.
• Identify platform constraints and recommend hardware, consumable, or software improvements.

Configuration and Change Control

• Own panel configuration management and traceability.
• Assess impact of assay, software, consumable, and instrument changes.
• Support design reviews, risk assessments, verification, and validation activities.

Verification and Validation

• Define integrated workflow test plans.
• Develop system-level performance studies.
• Support regulatory submissions and design control activities.

WHAT YOU WILL BRING:

The ideal candidate will possess:

• A bachelor's degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Systems Engineering, Biochemistry, Bioengineering, or a related scientific or engineering discipline.

• A Master of Science (M.S.) or Ph.D. is strongly preferred.

• 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

• Software-controlled workflows

• Experience with integrated diagnostic systems under FDA design controls.

NICE-TO-HAVE QUALIFICATIONS

• 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).

SUPERVISORY ROLE

• This is not a supervisory role

SALARY RANGE

$168,000 - $183,000

The salary range for this position represents the anticipated range for qualified candidates. Compensation decisions are based on a variety of factors, including relevant experience, skills, education, training, certifications, internal equity, market data, and business needs. The final compensation offered to a successful candidate will be determined based on these factors and the requirements of the role.

PHYSICAL DEMANDS AND ABILITIES

• Ability to safely lift, carry, and move materials weighing up to 5 pounds on a regular basis.
• Ability to remain stationary and move about the work environment as needed to perform job duties.
• Ability to perform visual tasks associated with the position, including reviewing data, inspecting materials, and operating laboratory or computer equipment, as applicable.
• Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.

Interested candidates are encouraged to submit a cover letter along with their resume. The cover letter is an opportunity to highlight how your experience in assay and/or panel architecture aligns with our mission, your approach to technical leadership and cross-functional collaboration, and how your expertise has driven innovation in diagnostic product development and complex assay systems.

Truvian is an Equal Opportunity Employer and is committed to fostering a diverse, inclusive, and respectful workplace. Employment decisions are made based on qualifications, merit, and business needs. Truvian prohibits discrimination, harassment, and retaliation and does not discriminate on the basis of any characteristic protected by applicable federal, state, or local law, including race, color, religion, creed, sex, pregnancy (including childbirth, breastfeeding, and related medical conditions), gender, gender identity, gender expression, sexual orientation, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, reproductive health decision-making, or any other legally protected status.

This policy applies to all aspects of employment, including recruitment, hiring, placement, promotion, compensation, benefits, training, transfers, leaves of absence, disciplinary actions, termination, and all other terms and conditions of employment. Truvian is also committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, in accordance with applicable law.