Design Software Quality Engineer

Posted 3 days ago

davis companiesDenver (CO)

SENIORITY

Lead

Apply

About the role

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

Before you apply

Applying takes about a minute. These four things decide how fast it moves after that.

Your profile is current

It's what we read first. Occupations, seniority and locations matter more than a long history.

Two examples you can talk through

Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.

A number in mind

What you're on now and what would make you move. We negotiate better when we know both.

Your notice period

Employers plan around it, and it's the question that stalls offers most often.

Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.

More like this