Hello this is Komal from Intellectt we have an opening for a Software Quality in Irving, TX. Please find the job details and description below and if interested You can reach me at komal@intellectt.com or call me at +1(732)-813-9025.
Role: Software Quality - Senior or Lead Engineer
Location: Irving, TX - 75038
Duration: 12 Months
Shift Timings: 8 to 5
Brief Synopsis
- The position will be providing software quality support for new medical device product development which includes activities and tasks related to the software development lifecycle (SDLC) and FDA design controls (ISO 13485).
- Education: BS degree in engineering, technical field or equivalent.
- Preferably software related such as computer science.
- Experience: Minimum 5 years medical device software development lifecycle (SDLC), FDA design controls, software quality engineering, software verification/validation including traceability to requirements and risk analysis, defect reporting, and software configuration management.
Top 5 skills/requirements :
- 5 years medical device software development lifecycle (SDLC); In Vitro Diagnostics (IVD) preferred.
- ISO 13485 (Medical Device QMS) and ISO 14971 (Medical Device Risk Management)
- FDA design controls (820.30)
- Software verification/validation experience
- Abbott experience preferred