Design Quality Engineer I

What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.SummaryIn this Design Quality Engineer I role, you will be a quality engineer on one or more product management teams expected to assist with assessments, evaluation, and implementation of design changes and processes for Illumina products driven by product risk management, post-market surveillance, components end of life, complaints, and other internal or market driven data. You will assist the teams with risk assessments, protocols writing, and documentation of resultsKey ResponsibilitiesSupport of change management activities for on-market productsSupport of impact assessments for design, process, and risk control activitiesReview engineering reports for accuracy and presence of sufficient data to support the changeReview change deliverablesSupport of Risk Management activities for on-market productsPerform Product Risk Management File updates and reviews, as requiredProvide feedback into new product development as requiredUpdate and maintain Design History Files as neededProvide management with status updates on assigned responsibilities and goals - escalating issues and proposing solutions as necessary.Take initiative to identify and implement improvements to the Illumina quality system.Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.QualificationsAbility to quickly learn the principles behind Illumina technology, design, and manufacturing processes requiredSome experience in working in a regulated environment, in-vitro diagnostic, development, quality engineering and/or manufacturing (employment or internship) preferredGood writing and presentation skills requiredKnowledge and capability in one or more statistical analysis tools (JMP, R, Minitab, Tableau, SAS, etc.) preferredPractical experience in design controls, risk management, process controls, change management, and post market surveillance preferredAdaptable to fast-paced, dynamic work environment with shifting demandsLess than 1 year no previous related experience; or equivalent work experienceEducation:Bachelor’s degree or higher (MS preferred) in technical field such as Chemistry, Biochemistry, Biomechanical Engineering, Physics, Mechanical Engineering etc.Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.