We are currently in need a consultant with experience directly developing swFMEAs & SDLC procedures, who can develop the software from scratch, not just managing the process.
Must have:
- IEC 62304 standard knowledge, software V&V & Software risk, as are all key elements of this role
- Solid knowledge of the SW development lifecycle in a simple and practical way is critical
- Software Quality (IEC 62304 standard requirements) and risk management (ISO 14971) as the need is to work through process and risk updates related to software.
My client is focused on developing and supporting innovative Class III products and needs someone for both sustaining and new product development activities, who will partner closely with Engineering, Manufacturing, Software, and Regulatory teams to ensure products are developed and maintained in compliance with FDA and international quality standards.
Please note, due to the nature of the work, only candidates that are US citizens, permanent residents or hold a green card will be considered at this point
Design Software Quality Engineer in United States at The Davis Companies
This position is listed as full time and onsite. It was posted 3 days ago.