Nanobiosym
  • 30-Jan-2020 to 31-Mar-2020 (EST)
  • Cambridge, MA, USA
  • Full Time

Nanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, 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 seeking a Software Quality Assurance Engineer.  This candidate will be tasked with owning the documentation generation of software requirement specs, software specifications, verification testing protocols, documentation, and other deliverables required by our established quality management system for ISO 13485.  This role will be supporting the commercialization of our pipeline of products and will be in conformance with FDA Regulations (21 CFR 820), ISO 13485, ISO 14971, and cGMP documentation.
 
Responsibilities include the following:
  • Candidate must have ISO 13485 experience
  • Identify and author the software requirement specification and own the software development plan.
  • Generate test protocols that verify the software meets the requirements
  • Contribute to the DVTP (design verification test plan) and software traceability matrix.
  • Review existing software code and create QMS documents.
  • Contribute to change documentation, Design History File (DHF), and Device History Records (DHR/Batch Records), Device Master Record (DMR), and configuration management plan.
  • Facilitate timely review of mission critical documentation and reviewing document drafts for format, clarity, grammar and spelling.
  • Engage in activity necessary to foster success for Nanobiosym's Quality Assurance and Regulatory Affairs functions in a cross-functional collaborative manner.
Minimum Requirements
         BS/BA degree required, Master's degree preferred, Software Engineering or electrical engineering.
         Knowledge of C/C++, Labview Assy, Android OS, and Java.
         5+ years of relevant software/device experience in an FDA regulated and ISO 13485 compliant environment.
         Advanced knowledge and skills in using Microsoft Word, Excel, & Access and Adobe software.
         Ability to write clearly with proper grammar and spelling.
         Highly organized individual that is detail-oriented.
 
Excellent communication and organizational skills.
High Personal Integrity and alignment with the Humanitarian mission of the company
Nanobiosym
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