Sr. Research Associate -Systems Integration

• 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. 

• 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.