Process Development Engineer II

Who we are Silk Road Medical, Inc. is a medical device company located in Sunnyvale, California & Plymouth, MN, that is focused on reducing the risk of stroke and has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR). We are always looking for dynamic and innovative individuals who are passionate about reducing the risk of stroke. We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others with a strong emphasis on collaboration. The opportunity The Process Development Engineer II contributes to cross-functional NPD (New Product Development) project teams under the direction of Senior or Principal level engineers. This is a hands-on engineering position where responsibilities include contributing to developing the manufacturing process, PFMEA, and manufacturing pilot/qualification builds as well as contributing to product design specifications, DVT, and other development team activities. This is an onsite position. A "Day in the life” Contribute cross-functionally to product design to ensure design for manufacturability. Design and perform process characterization and development activities (screening experiments, DOE, process mapping for inputs/outputs, equipment design and selection). Design and qualify process tooling, fixtures, and equipment. This may involve varying degrees of semi-automation. Create protocols, perform testing, analyze results, and document reports for process characterization and qualification activities. Creates manufacturing documentation (SOP’s and records). Contributes to PFMEA activities. Performs job safety risk assessments for new processes and equipment designs. Leads aspects of manufacturing pilot builds and IQ, OQ, PQ. Develops manufacturing processes with the operator in-mind (ergonomics, safety), Lean methodologies, waste reduction, one-piece flow, and Cycle Time / TAKT Time considerations in-mind. What you’ll bring Bachelor’s degree required; Engineering degree preferred. 2+ years process development experience in a manufacturing environment. Medical device experience preferred. Additional skills you have Ability to solve problems and deal with a variety of variables in pressure situations. Effective verbal and written communication skills. Excellent attention to detail, flexible, and adaptable to change. Ability to design fixtures and components in SolidWorks (CAD). Advanced analytical and mathematical skills including basic statistics. Must be self-motivated, highly organized, and resourceful in using scientific and engineering principles to solve manufacturing issues. Possesses a well-developed team orientation with strong critical thinking and analytical skills. Requires working knowledge in DFM, Lean Six Sigma methodologies, as well as DOE and Statistical Process Control. Occasionally, adjusting or moving objects up to 50 lbs. Occasionally, repeating motions that may include the wrists, hands, and/or fingers. Travel up to 10%. Come join our team where we celebrate diversity and embrace everyone's unique talents! We encourage individuals from all backgrounds to apply. What we offer Our philosophy is to make all benefits affordable to all Silk Road Medical employees and their dependents. We offer robust and affordable benefits with modest employee contributions. Click here for more information https://www.srmbenefits.com. Our Commitment to Diversity, Equity & Inclusion We welcome all people who want to be part of our amazing journey and mission to provide new, innovative, and clinically proven transcarotid therapies to prevent the devastating burden of stroke. Our employees come from very different backgrounds: different races and ethnic backgrounds, different religions, and different parts of the world. Some of us are married to people of the opposite sex and some to the same sex, some are not married. Some of us are becoming parents for the first time and others are counting down the days to retirement. Some of us do cartwheels every day and some need physical accommodation to best perform their role. All are welcome. We have a diverse workforce because we believe that it is possible for people with different backgrounds, viewpoints and persuasions to come together and debate important topics, learn from one another, and make better decisions than we would if we all were all the same. We want Silk Road Medical to not only be a great place to work, but The Greatest Place to Work and we strongly believe that a diverse and inclusive working environment is critically important to that goal. Silk Road Medical is an equal opportunity employer and we value diversity at our company. We strictly prohibit unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity, national origin/ancestry, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.