Do you love Quality, like in that weird way you really can’t explain but you just couldn’t imagine living without? Does the idea of championing the design control process make you giddy?
Have you trained a group of engineers and seen their glazed-over eyes brighten a bit as they started to catch the vision you were presenting? Have you personally built systems that people want to follow, not because they have to the meet regulations, but because they can see the inherent benefit?
We need you. We have the ambitious goal of taking multiple fully-implantable active Class II/III devices through market clearance in the next few years. And we thought, you know, while we are at it, we should take a handful of very complex high-end external electronic medical devices with really complicated software through a 510(k) submission too! Who doesn’t love a challenge?
We have just gained ISO 13485 certification for our QMS, but we need your help to improve and execute our system processes. We need a Quality Engineer who can comprehend standards into practices that make sense.
Heads up: We have A LOT of work to do. We need a Quality Engineer to drive design controls from concept. You will work daily with our engineering teams, seriously dedicated and creative engineers who need your help to capture, verify and validate their designs above scrutiny. We also need to implement manufacturing processes that are risk based, directed towards supplier qualification and new product transfer that are scalable.
This is a full-time, exempt position, starting immediately in our Salt Lake City office. This position reports to our Operations Manager, Alec Vogel.
About this Position
Here’s what we are looking for. If you have any of the following experience, then give us a holler:
- Required: A minimum of 3 years’ medical device experience in a 13485 QMS (we love you mining, oil and infrastructure engineers, but this position is only for experienced Medical Device Engineers).
- A minimum of 2 years’ experience with new product introduction activities including product design transfer efforts, implementing processes, reviewing, and approving plans and reports and supporting qualifications and validations per (820.30 & ISO 13485:2016 Section7.3) for class II and III medical devices.
- Software Design Life Cycle (SDLC) experience is a big plus.
And here’s what you will do in this position:
- Create and maintain Risk Management documents for products under Design Control and released products including Requirements facilitation, Risk Management Plan/Report, Risk Analysis Document, Risk Management File, dFMEA, sFMEA and pFMEA.
- Develop and maintain quality system procedures supporting medical devices.
- Initiate and manage technical files and design history files.
- Support supplier evaluations, audits, and qualifications.
- Collaborate with engineering department.
- Inspire everyone at Ripple in the virtues of Quality.
- Genuinely care – at Ripple, we care deeply about each other and treat each other with respect, kindness, and patience. We care about the products we create and demand the best of ourselves.