Sr. Research Associate -Systems Integration

About the Job

We are seeking a Senior Research Associate to drive systems integration efforts for our molecular diagnostics platform. This role sits at the interface of molecular biology and engineering and is responsible for the transition and optimization of molecular and biochemical processes onto automated sample-to-answer molecular diagnostic instrument platform and consumable.

Key Responsibilities

• Build, characterize, and iterate on early prototype instrument and consumable systems, working closely with engineering, assay development, and chemistry teams.

• Lead integration testing, risk analysis, and troubleshooting across development cycles.

• Design and execute studies to characterize consumable performance (e.g., flow cell fluidics, reagent cartridges, sample prep modules) across manufacturing lots and design iterations.

• Support development and troubleshooting of fluidic and flow cell–based systems, including flow path design, priming/wetting behavior, bubble management, dead volume, and flow uniformity.

• Operate and troubleshoot fluorescence-based detection systems (imaging or plate-reader based), evaluating performance using metrics such as signal intensity, background, specificity, sensitivity, and reproducibility.

• Translate bench-scale sample preparation, molecular processes and detection chemistries into integrated, system-compatible workflows.

• Define and execute integration testing protocols spanning fluidics, electronics/instrumentation, and assay chemistry to identify failure modes and performance bottlenecks.

• Generate and maintain rigorous documentation (protocols, data records, technical reports) suitable for design history files and regulatory submissions.

• Collaborate with quality and regulatory functions to ensure development work aligns with GMP/ISO/FDA design control requirements as the program advances toward verification and validation.

• Contribute to design-for-manufacturability and design-for-reliability discussions for consumable and instrument subsystems.

• Collaborate cross-functionally with Assay Development, Reagent Chemistry, Device/Instrument Engineering, Manufacturing, and Quality/Regulatory teams to transition surface chemistry processes from R&D through pilot scale-up and into IVD manufacturing under design control.

• Design and execute DOEs to optimize coating uniformity, reproducibility, shelf-life/stability, and lot-to-lot consistency; support root cause investigations and CAPAs related to surface chemistry performance.

• Author and maintain technical reports, protocols, batch records, DHF/design control documentation, and contribute to regulatory submissions (e.g., FDA 510(k)/PMA, CE-IVDR) as needed.

• Support IP strategy, including invention disclosures and patent support.

• Present data and recommendations to cross-functional project teams and leadership.

Qualifications

Required Qualifications

• BS/MS in Biomedical Engineering, Chemical Engineering, Bioengineering, Molecular Biology, Chemistry, or related field, with 5+ years of relevant industry experience (or equivalent combination of education and experience)

• Demonstrated experience in product development with early prototype systems — comfortable working with immature hardware, ambiguous specs, and iterative design cycles

• Hands-on experience with consumable characterization — designing test methods, defining acceptance criteria, and driving root-cause analysis on consumable performance issues

• Hands-on experience with fluorescence imaging and/or fluorescence spectroscopy instrumentation, including image/data analysis for signal characterization

• Experience working with fluidic and/or flow cell–based systems (microfluidics, cartridge-based systems, or similar) — understanding of flow behavior, fluid handling, and common failure modes

• Experience working in a regulated environment (GMP, ISO 13485, FDA design controls) with familiarity in documentation practices supporting design history files and quality systems

• Working knowledge of molecular biology techniques relevant to nucleic acid-based diagnostics (nucleic acid extraction/purification, PCR or isothermal amplification, sample preparation workflows)

• Strong hands-on laboratory skills, meticulous record-keeping, and the ability to troubleshoot systematically across chemistry, biology, and hardware domains

• Excellent written and verbal communication skills; ability to synthesize data into clear reports for cross-functional audiences.

Preferred Qualifications

• Experience with in vitro diagnostics (IVD) product development, particularly molecular diagnostics or point-of-care platforms.

• Experience with automated liquid-handling systems is a plus

• Familiarity with whole blood sample handling, including cell lysis, nucleic acid depletion/enrichment strategies, or blood-based sample stabilization/cryopreservation.

• Experience supporting verification and validation (V&V) activities or transfer to manufacturing.

• Statistical data analysis skills (e.g., JMP, Minitab, Python/R) for characterization and DOE studies.

Education

BS/MS in Biomedical Engineering, Chemical Engineering, Bioengineering, Molecular Biology, Chemistry, or related field, with 5+ years of relevant industry experience (or equivalent combination of education and experience)

Benefits & Perks

Sarmal offers a competitive and comprehensive benefits package, including:

• Medical, dental, and vision coverage
• Company-paid life insurance
• 401(k) retirement plan
• Generous paid time off
• Access to additional voluntary benefits, employee perks, and discount programs
• We are committed to supporting the well-being of our employees and providing a strong foundation for both professional and personal success.