{"id":3025246,"url":"https://alion.io/job/ebr-systems-inc-senior-manufacturing-engineer","title":"Senior Manufacturing Engineer","company":{"id":3790005,"name":"EBR Systems, Inc","domain":"ebrsystemsinc.com","url":"https://alion.io/company/ebrsystemsinc","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paylocity","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Santa Clara, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":122500,"max":157500,"currency":"USD","period":"year","gross":null,"usd_annual":157500},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"SolidWorks","optional":false}],"status":"live","first_seen_at":"2026-10-21T17:08:50Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-11-03T09:44:27Z","board_verified":true,"closed_at":null,"days_open":12,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":12},"description":"Description\nAbout EBR Systems\nAt EBR Systems, we're not imagining the future of cardiac care. We're building it. We are the team behind the world's first FDA-approved leadless left ventricular endocardial pacing device for heart failure. It's a breakthrough that's redefining what's possible, and it's just the beginning.\nBased in Silicon Valley, we're advancing the WiSE System, a first-of-its-kind device in cardiac rhythm management. Your work here has a direct line to patients whose lives depend on what we build.\nWe hire people who want to solve hard problems and who care about getting it right. We invest in our people as much as our technology. Expect a collaborative, transparent culture, real career growth in a fast-moving startup, competitive compensation, equity, comprehensive benefits, and generous PTO. If you want your work to matter, EBR is where you belong.\nSUMMARY OF THE POSITION:\nThe Senior Manufacturing Engineer provides technical leadership for manufacturing processes, equipment, and product transfers to support development, commercialization, and sustaining operations. This role is responsible for developing, implementing, and continuously improving manufacturing processes that ensure product quality, regulatory compliance, operational efficiency, and scalability.\nThe Senior Manufacturing Engineer serves as a subject matter expert for complex manufacturing challenges, leads cross-functional improvement initiatives, and provides technical guidance to manufacturing, quality, supply chain, and product development teams. The role operates with limited supervision and is expected to independently manage significant projects while influencing manufacturing practices and decisions within a product line or manufacturing area.\nESSENTIAL AND OTHER DUTIES AND RESPONSIBILITIES:\nManufacturing Process Leadership\nLead the development, qualification, optimization, and continuous improvement of manufacturing processes.\nEstablish and maintain process controls, tooling strategies, operating parameters, and validation approaches to ensure consistent product quality and performance.\nProvide technical leadership and support to manufacturing operations for process capability, efficiency, and compliance initiatives.\nSupport manufacturing planning and process improvements across development, transfer, launch, and sustaining activities.\nProduct and Process Development\nLead development and optimization of manufacturing processes to meet quality, cost, delivery, and regulatory requirements.\nDefine and execute process characterization studies, DOE activities, and process capability assessments.\nProvide manufacturing expertise during product development to support design-for-manufacturability, scalability, and robust process performance.\nCollaborate with cross-functional teams to ensure manufacturing requirements are incorporated into product and process designs.\nManufacturing Transfer and Scale-Up\nLead manufacturing transfer activities from development to production and between manufacturing sites or contract manufacturers.\nDevelop and execute qualification plans, readiness assessments, and production ramp-up activities.\nSupport technical engagement with contract manufacturing partners to ensure alignment with manufacturing and quality requirements.\nEstablish transfer criteria and manufacturing readiness requirements for new products and processes.\nSustaining Engineering and Continuous Improvement\nLead investigations and resolution of complex manufacturing issues, non-conformances, and process deviations.\nDefine corrective actions and risk mitigation strategies for recurring or systemic manufacturing issues.\nDevelop and implement improvements that enhance yield, reliability, throughput, and process robustness.\nUtilize data-driven approaches to identify and execute continuous improvement opportunities.\nTooling, Equipment, and Validation\nDefine requirements and specifications for manufacturing equipment, tooling, fixtures, and automation systems.\nLead equipment and process qualification activities, including IQ, OQ, and PQ protocols and execution.\nEnsure manufacturing processes and systems remain in a validated and compliant state.\nSupport capital equipment selection, implementation, and lifecycle management activities.\nCross-Functional Leadership\nLead technical alignment activities across Manufacturing, Quality, Regulatory, Supply Chain, Operations, and R&D.\nRepresent Manufacturing Engineering in design reviews, program reviews, change control reviews, and leadership discussions.\nMentor Manufacturing Engineers, Technicians, and cross-functional team members in manufacturing best practices and problem-solving methodologies.\nCoordinate cross-functional efforts required to achieve project and operational objectives.\nDocumentation and Compliance\nDevelop and maintain manufacturing documentation, including procedures, work instructions, validation protocols, reports, and technical assessments.\nEnsure compliance with FDA Quality System Regulations, ISO 13485 requirements, and internal quality system procedures.\nSupport change control, risk management, process validation, and audit readiness activities.\nDrive consistent application of engineering, validation, and quality system practices.\nSUPERVISORY RESPONSIBILITIES:\nProvide technical leadership, mentorship, and direction to Manufacturing Engineers, Process Technicians, and Manufacturing Technicians.\nMay lead project teams or coordinate technical activities across multiple functional groups.\nServes as a technical resource and mentor for less experienced engineering staff.\nDoes not typically have direct people-management responsibility but may provide project leadership and technical oversight.\nQUALIFICATIONS:\nEducation and Required Experience:\nBS in an Engineering discipline such as Industrial or Mechanical.\nMinimum of 6 years of medical device manufacturing experience required.\nAdvanced degrees in engineering, biomedical sciences, or related fields will be considered for reduced experience requirements.\nKnowledge, Skills, and Abilities:\nSolidWorks experience required.\nExperience with equipment, tooling, and fixture design.\nExperience with root cause analysis and problem-solving tools for both technical and process issues.\nKnowledge of Lean and Six Sigma tools.\nWorking knowledge of cGMP requirements for medical device manufacturing per FDA QSR and ISO 13485.\nPHYSICAL REQUIREMENTS:\nRequired to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend, crouch and lift up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.\nSubject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.\nSalary Range:\n$122,500 - $157,500\n*Base pay is one part of your total compensation. The salary offered will depend on several factors, including, but not limited to your experience, knowledge, skills, location, internal equity, and market alignment. Addition compensation may include bonuses and equity, along with a comprehensive benefits package.\nEBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.\nAbout the Company:\nWhat if your work doesn't just support innovation-what if it changes lives?\nWe don't just create game-changing medical devices-we grow people. Patients come first in everything we do. You will be empowered to solve real problems and to do meaningful work that truly makes a difference.\nIf you are driven by purpose, excited by challenge, and ready to shape the future of cardiac technology, we want to hear from you.\nVisit us at https://www.ebrsystemsinc.com/ to learn more-and join us in our work Empowering Physicians, Powering Hearts.\nEBR Systems, Inc. offers a great place to work as well as generous benefits and growth opportunities\nMedical, dental, and vision insurance provided at no cost for employee-only coverage\n 401(k) matching plan\nPaid Time Off - starting at 3 weeks per year\nCompetitive salary with opportunities for career growth\nEmployee stock options\nLife & AD&D and long term disability insurance\nEducation assistance\nVoluntary commuter benefits and pet insurance\nWeekly company lunches and occasional happy hour events\n Meaningful work and much more!\nEqual Opportunity Employer 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