SiPhox Health · 1 week ago
Senior Assay Development Scientist/Engineer
Burlington, MA
Full-time
Onsite
Mid, Senior Level
4+ years expSiPhox Health is redefining clinical immunoassay diagnostics by miniaturizing the analytical power of a central lab into an accessible, affordable, at-home platform. The Senior Assay Development Scientist/Engineer will develop innovative immunoassays and collaborate across teams to enhance assay performance and scalability for consumer health applications.
Health CareHealth DiagnosticsMedical Device
Responsibilities
Develop quantitative sandwich and competitive immunoassays (including free hormone assays, displacement-driven formats, and low-abundance biomarkers) on a silicon-photonic resonance platform
Design, execute, and interpret experiments focused on: Binding kinetics & equilibrium optimization, Surface functionalization strategies, Competitive assay dynamic-range shaping, Calibrator and control development (matrix selection, commutability), Assay precision, stability, robustness
Own assay verification and validation aligned with CLSI standards (EP05, EP06, EP07, EP09, EP10, EP17)
Establish and demonstrate performance for: Analytical sensitivity & functional limit (LoB/LoD/LoQ), Linearity & reportable range (including hook effects, competitive assay inflection characterization), Repeatability, reproducibility, and nested CV analysis, Interference and cross-reactivity studies, Matrix equivalency & recovery studies, Build calibration models for a novel platform (e.g., 4PL/5PL, competitive curve inversion, chip-specific normalization frameworks)
Collaborate deeply with photonics, microfluidics, reader electronics, manufacturing, and product engineering teams to close the loop on real-world assay performance
Work with process development and chemistry groups to scale assays from prototype to production, enabling high-volume, chip-based manufacturing
Deliver high-clarity technical reports, protocols, V&V documentation, and design-history file content that meets IVD and FDA expectations
Present results across the company to inform design decisions and product milestones
Qualification
Required
PhD + 2 years, or MS + 6 years in biochemistry, chemical engineering, analytical chemistry, biophysics, bioengineering, or related fields
Expertise in immunoassay development (sandwich and competitive). Experience with free hormone assays is a major plus
Demonstrated ability to independently solve complex analytical and biochemical problems
Hands-on experience with complex analytical workflows, assay automation, and instrumentation
Strong understanding of calibration design, commutability, and control strategies
Familiarity with statistical analysis of assay performance, including mixed-model ANOVA, CV decomposition, and method-comparison frameworks
Strong scientific intuition paired with rigorous data discipline
Thrives in a fast-paced, milestone-driven startup environment
Creative problem solver willing to challenge established assay paradigms
High integrity, willingness to own outcomes, and a collaborative mindset
Preferred
Experience with IVD development, ISO 13485, or 21 CFR 820
Experience with POC or novel-platform assay development
Knowledge of label-free sensors, waveguides, or photonic resonance systems
Experience with Python, R, or MATLAB for data analysis, curve fitting, and automation
Company
SiPhox Health
SiPhox Health builds diagnostic infrastructure both for the home and the central lab.
11-50 employees
H1B Sponsorship
SiPhox Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (1)
2022 (1)
Funding
Current Stage
Early StageTotal Funding
$32.8MKey Investors
Khosla Ventures
2025-03-04Series A
2023-07-19Series A· $17M
2023-07-19Seed· $10M
Leadership Team
Michael Dubrovsky
Co-Founder
Recent News
Google Patent
2025-04-02
2025-04-02
BostonGlobe.com
2025-02-11
Company data provided by crunchbase