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Quality Engineer

Company: Ripple LLC
Location: Salt Lake City
Posted on: February 23, 2021

Job Description:

Do you love Quality, like in that weird way you really can't explain but you just couldn't imagine living without? Does the PA in CAPA make you giddy? Do you dream of a perfect Trace Matrix?
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 scalable.
This is a full-time, exempt position, starting immediately in our Salt Lake City office. This position reports to our Quality Leader, Mike Gomez.
About this PositionHere's what we are looking for. If you have any of the following experience, then give us a holler:

  • Required: 2-8 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)
  • Development and maintenance of quality system procedures supporting a medical device
  • Collaborates with operations, manufacturing, engineering, and regulatory functions to ensure quality standards are in place. Collaboration is a must; we want a quality team that breaks the mold from a stereotypical quality role.
  • Manufacturing risk control and process validation
  • Support of supplier quality
  • Inspection and test method development
  • New product development including design controls and transfer to manufacturing
  • CAPA and NCR management
  • Experience with IEC 62304 is preferred, but not required
  • Internal and external audit experience
  • A bachelor's degree in a technical discipline and a minimum of two to eight years of practical experience as a Quality Engineer in support of a commercially available Class II/III active implantable medical device or an equivalent combination of education and experience
  • Moderate to high level of creativity and a demonstrable ability to solve complex problems.
  • Inspire everyone at Ripple in the virtues of Quality.
  • Help develop the culture of the company.
  • Be thoughtfully constructive: We are looking for solution-oriented team players who can check their egos in order to collaborate to overcome obstacles.
  • 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.
  • Believe in Quality! All Ripplers are committed to making everything we build or design exceptional by being proactively involved in the quality process.
    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 totally willing to make reasonable accommodations to enable individuals with disabilities to perform this job.
    About RippleRipple creates life enhancing neurotechnology for research and medical applications. 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 and grants from NIH, DARPA, and the Congressionally Directed Medical Research Program (*sigh* that was a mouthful.)
    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.
    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 are passionate and friendly, patient and thoughtful, and 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 of friends building them together, it is worth it.
    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 to see what you can do to make them even better?
    Then what are you waiting for? Send your resume on over to with a cover letter explaining your interest in this position, and in working for Ripple.
    We are excited to hear from you!

Keywords: Ripple LLC, Salt Lake City , Quality Engineer, Engineering , Salt Lake City, Utah

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