11 часов назад
Senior Research Associate - Systems Integration (Molecular Diagnostics)
72 000 - 85 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Research Associate - Systems Integration (Molecular Diagnostics): Building and optimizing integrated molecular diagnostic instrument and consumable systems with an accent on fluidics, fluorescence detection, molecular workflows, and surface chemistry. Focus on designing integration tests and DOEs, troubleshooting cross-domain failure modes, and supporting regulated product development through verification, manufacturing transfer, and regulatory submissions.
Location: San Diego, California, United States; Workplace: On-site
Salary: $72,000–$85,000 per year, depending on experience and qualifications
Company
is an early-stage biotechnology company developing genomics and molecular detection platforms that integrate molecular biology, chemistry, and systems engineering.
What you will do
- Build, characterize, and iterate on prototype molecular diagnostic instruments and consumable systems.
- Lead integration testing, risk analysis, troubleshooting, and failure-mode investigations across development cycles.
- Design studies and DOEs to characterize fluidics, flow cells, reagent cartridges, sample preparation modules, and surface chemistry performance.
- Operate fluorescence imaging or spectroscopy systems and analyze signal intensity, background, specificity, sensitivity, and reproducibility.
- Translate molecular biology, sample preparation, and detection chemistry processes into automated, system-compatible workflows.
- Document development work and collaborate with engineering, assay development, chemistry, manufacturing, quality, and regulatory teams through scale-up and IVD production.
Requirements
- BS/MS in biomedical engineering, chemical engineering, bioengineering, molecular biology, chemistry, or a related field, plus 5+ years of relevant industry experience or an equivalent combination.
- Product development experience with early prototypes, immature hardware, ambiguous specifications, and iterative design cycles.
- Hands-on experience characterizing consumables, defining test methods and acceptance criteria, and performing root-cause analysis.
- Experience with fluorescence instrumentation, fluidic or flow cell-based systems, and molecular biology techniques for nucleic acid diagnostics.
- Experience in regulated development environments, including GMP, ISO 13485, FDA design controls, design history files, and quality-system documentation.
- Strong laboratory, troubleshooting, documentation, written communication, and cross-functional collaboration skills.
Nice to have
- Experience developing in vitro diagnostics, molecular diagnostics, or point-of-care platforms.
- Experience with automated liquid-handling systems and whole-blood sample handling.
- Experience supporting verification and validation or manufacturing transfer.
- Statistical analysis experience with JMP, Minitab, Python, or R.
Culture & Benefits
- Collaborative, cross-disciplinary R&D environment with a builder mindset.
- Work on genomics and molecular detection technologies at an early stage of development.
- Medical, dental, and vision coverage.
- Company-paid life insurance and a 401(k) retirement plan.
- Paid time off, voluntary benefits, employee perks, and discount programs.
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