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Nanobiosym, Inc. Clinical Validation Testing Associate in Cambridge, Massachusetts

23-Jan-2024 to 15-Apr-2024 (EST) | Cambridge, MA, USA | Full Time

Nanobiosym is on the cusp of rewriting the rules of personalized medicine, mobile diagnostics, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a recipient of multiple other prestigious peer-reviewed funding awards, Nanobiosym is currently adding to its talented team as it expands into a global commercial enterprise.

Nanobiosym is currently seeking talented clinical validation test engineers with device testing experience. This role will include a combination of data collection, data acquisition, troubleshooting, and the development of testing procedures.

DUTIES

  • Has experience working in a BSL2 or BSL2+ facility

  • Experienced handling clinical samples in BSL2 facility

  • Must have 3-5 years experience in a CLIA LAB setting

  • Perform device testing, maintain laboratory records, and prepare reports.

  • Define strategy for testing and optimization.

  • Create and champion new internal processes of testing, data collection, data acquisition, and data analysis

  • Exercise technical judgment on test requirements, developing recommendations and translating into course of action

  • Experience working in an ISO regulated facility and a working knowledge of ISO documentation & QSR requirements.

    QUALIFICATIONS

  • BA/BS degree in Molecular Biology, or equivalent practical experience

  • MS in Molecular Biology Preferred

  • Academic or practical experience in molecular biology preferred

  • Experience working in highly regulated industries (i.e.FDA)

  • Minimum 5 years of clinical validation testing experience

  • Testing experience within a life science setting preferred

  • Experience working in a GMP-regulated environment testing and/or developing life sciences products or devices including meticulous laboratory notebook skills preferred

  • Must have an understanding of principles of statistics relevant to product testing

  • Must have an understanding of failure mode and root cause analysis

  • Experience working in fast-paced startup environments preferred

  • Experience working as key tester or the only test engineer ideally in medical devices or mobile health tech products, with experience in verification and/or validation testing.

  • Experience with automation tools (i.e. run automation scripts, analyze reports and issues, report bugs)

    Personal Qualities

  • You are passionate about testing, quality assurance, healthcare, and technology

  • You are highly organized

  • You are methodical, detail oriented and effective at time management

  • You are a self-starter

  • You have good interpersonal, verbal communication, and documentation skills

  • You can function well in a challenging and fast-paced environment

  • You are enthusiastic and positive, with strong skills in the areas of dependability, flexibility, and maturity

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