Quality Engineer – Design and Development (Medical Device)

Salt Lake, UT  ·    Full time

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.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. We are a team. We pitch in and help each other on all projects. If you are “above” doing certain tasks, Ripple is definitely not a good fit for you.

Ripple is committed to equal employment opportunities and does not discriminate on the basis of any protected class defined by the Equal Employment Opportunity laws. Yeah, I know. You’ve heard it a million times, but we really do mean it. We find value in a diverse workplace. We are also willing to make reasonable accommodations to enable individuals with disabilities to perform this job.

About Ripple

Ripple delivers game-changing neurotechnology that greatly advances human health and potential. Our products integrate cutting-edge hardware and software elements designed to read and write from the human nervous system. We are funded by our sales revenue, contract design and engineering business, and grants from NIH and DARPA.

Executing this mission requires smart ideas, amazing people, and lots of hard work. To succeed we strive daily to find the best in ourselves as individuals and endeavor to approach our work together with intention, sincerity, and passion.

At its core, Ripple is a community of driven people who are choosing to work together on really hard problems. We are builders and creators and want to see our efforts impact the world for good. Those who thrive at Ripple are self-motivated and work well independently. There are times of intense effort and individual contribution and sacrifice, but we know that what we are building will take time, and living a fulfilling life outside of Ripple will keep team members deeply engaged.

Ripplers are given high-level tasks and a bit of context. Then, they are expected to seek out information, standards, develop new skills and design something great with a team of similarly dedicated and driven colleagues. If you are looking for micromanagement, this is not the place. We encourage individuals to engage in finding solutions to the problems we encounter.

At Ripple, team members are often asked to do things they have never done before. We expect a lot of chances to hear differing opinions, and to be surrounded by people who deeply care about our projects and are interested in the big picture of what Ripple is trying to accomplish. Ripplers are encouraged to take time to help and teach others, and to listen, learn and change their own views until a solution emerges.

We expect great ideas to come from everyone at Ripple. We balance passion and open-mindedness; we strive relentlessly for self-improvement; we own our mistakes and aim to improve, and we all agree to not work with jackasses (no matter how great you think you are). All of us must actively contribute to the quality of our processes and products through thoughtful effort. There is no shortcut to making implantable medical devices or cutting-edge neuroscience tools, but with a strong team building them
together, we can do it.

Next Steps

What do you think? Are you into it? Does this job posting make you warm and fuzzy inside? Are you already on our website checking out our products?

Then what are you waiting for? Send your resume on over to jobs@rppl.com with a cover letter explaining your interest in this position, and in working for Ripple.

We are excited to hear from you!

Please click here to learn more.