\nPassionate about precision medicine and advancing the healthcare industry?\n\nRecent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.\n\nResponsibilities:\n\n\nSupport the development of new or improved In Vitro Diagnostics products and Laboratory Developed Tests as core team Design Quality Engineering lead; providing collaborative, solution-oriented technical guidance and support to the team\n\nAssist in the determination of appropriate deliverables and generating project timelines.\n\nSupports the sustainability and life cycle management of existing products\n\nEnsures compliance with quality system and regulatory requirements related to product and process\n\nProvide Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development\n\nEvaluate adequacy of specifications for new or modified process designs.\n\nSupport product and customer requirement definition and development\n\nParticipate in Design Verification, Validation, and Process Validation Planning, Protocol Review, Report Review.\n\nRecommends design or test methods and statistical process control for achieving required levels of product reliability.\n\nReviews and analyze  performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.\n\nPerforms design change control activities including impact assessments, reviews, and approvals\n\nTakes lead role in CAPA, non-conformances, and planned deviations activities such as investigation, implementation, or verification of effectiveness as required\n\nSupports risk management activities in collaboration with the Risk Manager as they relate to product development and post market surveillance requirements\n\nReview the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities)\n\nSupport development master validation plans and reports.\n\nProvide technical support (subject matter expert) during audits (internal and third-party)\n\nPrepare documentation to support design history files and regulatory submissions ensuring documents are complete and accurate\n\nMaintain DHF and Propose, plan and execute improvement projects, as required for product sustainability\n\nDevelop/update departmental procedures and other controlled documents.\n\nParticipate in Material Review Board (MRB) and Change Review Board meetings, as required.\n\nTrain and mentor new employees. Provide guidance and direction to the team.\n\nPlans, executes, and works with minimal supervision and independent judgment\n\n\n\n\nQualifications:\n\n\nMust have experience working with all classes of Medical devices preferably IVDs in a QE role. Previous CDx experience a plus\n\nAbility to demonstrate proficiency in design of experiments, IVDD/IVDR requirements, Risk management file generation and remediation, problem analysis and resolution.\n\nDemonstrates leadership skills to handle sustaining product support activities involving Complaint investigations and Change controls.\n\nExtensive cross-functional team experience, including technical and non-technical work.\n\nStrong interpersonal and communication skills.\n\nStrong leadership skills and ability to work in a team environment\n\nHighly motivated hands-on engineer with a proven record of meeting timelines and goals\n\n\n\n\nEducation and Experience:\n\n\nB.S. degree in Degree in a chemistry, biology, or engineering discipline is a plus with 7+  years of experience working in a regulated environment in the in-vitro diagnostic, medical device, biotech or pharmaceutical industry. \n\nAdvance knowledge of applicable regulations including:  21 CFR Part 820, ISO 13485, ISO 14971\n\n\n\n\n\nExperience with process validation, analytical methods validation, and equipment qualifications.\n\n\n\n\n\nDemonstrated success in delivering results on several technical challenges.\n\n\n\n\n\nWorking knowledge of medical device domestic and  international standards.\n\n\n\n#LI-SH1\n#LI-Hybrid\n#LI-Remote\n#LI-Onsite \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design and Engineer jobs that are similar:\n\n $65,000 — $115,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nChicago, Illinois, United States