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.
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.
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)
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