Staff Manufacturing Engineer

Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery. We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.SUMMARY OF ROLE:Staff Manufacturing Engineer drives and provides support of products, processes, and equipment to achieve development and/or production goals. The engineer develops manufacturing processes to implement innovative improvements. The engineer works cross-functionally to validate processes and transfer new products into manufacturing.RESPONSIBILITIES:Support process development and validation activities across various manufacturing product linesDesign, develop, test and implement manufacturing process systems to ensure robust production processes, human work factors and quality controlDesign, develop and propose improvements for manufacturing process, equipment and systems using knowledge of engineering principles, industry standards and working design to meet production requirements, performance, quality, and safety standardsEmploy six sigma tools and scientific and statistical expertise to perform root cause and correlation analysis to identify and develop corrective actions for solving product and process failuresTransfer new products & processes into manufacturing, including support of R&D buildsCreate, update, and maintain manufacturing documentation that meets compliance requirementsPartner with outsourced vendors and suppliers to support production and resolve technical issues, working closely with MPI to establish and onboard new vendorsSupport manufacturing engineering efforts to meet production goals including resolution of non-conformances and line issuesPerform other duties, as assignedQUALIFICATIONS:B.S. in Mechanical, Biomedical or Industrial Engineering preferredComprehensive SolidWorks knowledge with experience creating manufacturing fixtures, tooling, and equipment modelsMinimum 10 years of experience in medical device industry and electro-mechanical device manufacturing preferredExperience with Lean/Six Sigma tools and proficiency with statistical methodologies preferredDemonstrated technical acumen in navigating regulated environmentsExcellent interpersonal, writing, and verbal communication skillsDemonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of qualityStrong judgment & decision-making abilityExcellent problem-solving skills, ability to diagnose issues and provide solutionsExperience with adhesives and electronics preferred and background with medical device disposables and capital equipment a plusStrong technical expertise with manufacturing processes, automation, and materialsBENEFITS:Element Science offers a very competitive salary and benefits package including, but not limited to:Stock Options90% employer-paid medical, dental, and vision insuranceCompany-paid Basic Life Insurance401(k) retirement plan (Traditional and Roth)Competitive Paid Time OffPaid HolidaysFSA (Flexible Spending Accounts)HSA (Health Savings Account)Employee Assistance Program through PEO