Nanobiosym
  • 09-Nov-2017 to 31-Dec-2017 (EST)
  • MA, USA
  • Full Time

Nanobiosym is an innovative nanotechnology company in Cambridge, MA that is developing novel technologies. 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.

DUTIES

  • 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

QUALIFICATIONS

  • 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)

 Personal Qualities

  • 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
Nanobiosym
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