Nanobiosym is an innovative nanotechnology company in Cambridge, MA that is developing point-of-care diagnostics to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine.
Nanobiosym is currently seeking talented test engineers with device testing experience.
This role will include a combination of standards interpretation, test protocol writing, report creation, data collection, data acquisition, troubleshooting, and the development of manufacturing testing procedures.
- Perform device testing, maintain laboratory records, and prepare reports for product validation and verification.
- Conduct and document product testing to determine compliance with applicable US and international standards and regulations
- Create and maintain test plans and test reports for existing and yet-to-be released products.
- 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
- Work real-time with others on test design and implementation and to evaluate testability of new features/implementations.
- Support root cause analysis for laboratory and product investigation
- Contribute to risk assessment activities and hazard analysis.
- Devise innovative approaches to engineering problems
- BA/BS degree in Engineering, Science, or equivalent practical experience
- Experience and knowledge of ISO13485 and/or GMP environments.
- Experience working in highly regulated industries (i.e. automotive, aviation, or FDA)
- A life science and/or medical device industry preferred
- Minimum 5 years of testing experience.
- Past experience of authoring documentation such as test protocols and reports.
- Must have strong mechanical aptitude
- Must have an understanding of principles of statistics relevant to product testing
- Must have an understanding of failure mode effects and root cause analysis
- Must be comfortable working in fast-paced startup environments.
- 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. labview, run automation scripts, analyze reports and issues, report bugs)
- You are passionate about testing, quality assurance, healthcare, and mobile technology
- You are methodical, detail oriented, well organized 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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