We are searching for a Software Quality Engineer for a rapidly growing medical devices company. The software quality engineer will support development and testing of product software to meet user and technical requirements and design specifications, while ensuring compliance with FDA and worldwide Regulatory Body regulations and guidance. This exciting and rapidly growing company is expected to go public later this year.
Requirements for the Software Quality Engineer:
- Bachelor’s degree in Computer Science, Software Engineering, Information Systems/Technology, or related engineering field with 5+ years of relevant industry experience in software quality engineering; OR Master’s Degree with a minimum of 3 years of relevant industry experience in software quality engineering
- Familiarity with Medical Device Software Development regulations such as IEC 62304 and FDA Guidance for software contained in medical devices.
- Quality engineering experience with medical devices containing software (Class II/Class B at minimum and Class III/Class C preferred)
- Knowledge and experience with Medical Device Quality Systems (ISO 13485 & 21 CFR Part 820) & Risk Management per ISO 14971
- Experience with Software Human Factors & Usability Engineering
- General understanding of SAAS, IAAS, and PAAS for Microsoft Azure environments
- General understanding of Waterfall & Agile software development methodologies
Occupational Category: 5-1252 Software Developers
: Please apply using the form or send your resume to Debbie Winkelbauer