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Senior Systems Engineer Instrumentation - 12 Month - Binx Health
Systems Engineer
Senior Systems Engineer responsible for designing, integrating, and validating instrumentation for a FDA‑cleared, CLIA‑waived point‑of‑care molecular diagnostic platform.
About the role
Key Responsibilities
- Design and develop instrumentation hardware and firmware for a rapid molecular testing platform.
- Integrate sensors, optics, and fluidics to meet FDA clearance and CLIA‑waived requirements.
- Lead verification, validation, and risk‑analysis activities across the product lifecycle.
- Collaborate with cross‑functional teams (software, mechanical, quality) to ensure seamless system integration.
- Provide technical support for manufacturing scale‑up and field troubleshooting.
Requirements
- Bachelor’s or higher in Electrical Engineering, Biomedical Engineering, or related field.
- 5+ years of experience in instrumentation and systems engineering for medical devices.
- Hands‑on expertise with hardware design, signal acquisition, and embedded firmware.
- Strong knowledge of FDA regulatory pathways and CLIA‑waived diagnostic standards.
- Proven ability to work in fast‑paced, cross‑functional environments and deliver on tight timelines.
Skills
software developmentsystem designproblem solving