{"id":2933399,"url":"https://alion.io/job/cognito-therapeutics-inc-senior-systems-engineer","title":"Senior Systems Engineer","company":{"id":2151697,"name":"Cognito Therapeutics, Inc.","domain":"cognitotx.com","url":"https://alion.io/company/cognitotx","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":98000,"max_usd":193000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1015},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"FMEA","optional":false},{"name":"Verification & Validation","optional":false},{"name":"21 CFR Part 820","optional":true},{"name":"IEC 60601","optional":true},{"name":"IEC 62304","optional":true},{"name":"IEC 62366","optional":true},{"name":"ISO 13485","optional":true},{"name":"ISO 14971","optional":true}],"status":"live","first_seen_at":"2026-10-13T13:38:50Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-29T11:21:21Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"description":"This is a rare opportunity to join a team that is bringing an entirely new category of brain health to the world. At Cognito, we are developing therapies designed to promote dignity, clarity, and coherence in the lives they touch. \nCognito is a neurotechnology company developing a new therapeutic approach to cognitive and neurological health, designed to work with the brain's own activity and biology. Born from pioneering neuroscience research at MIT, Cognito brings together neuroscience, engineering, medicine and technology to translate breakthroughs in brain science into practical therapies designed for everyday life. \nOur first therapeutic application, Spectris AD, is an investigational, prescription, at-home therapy for Alzheimer's disease. With our pivotal HOPE study now complete, Cognito is entering an important new phase as we advance Spectris AD toward regulatory review, prepare for potential commercialization and continue exploring the broader potential of our science across neurological health. \nWe are building an interdisciplinary team united by a shared purpose: protecting and progressing the human ability to think, learn and remember. For innovators who want to work at the intersection of breakthrough science, technology and human health, Cognito offers the chance to help shape what comes next.\nAbout the Job\nCognito Therapeutics is seeking a Senior Systems Engineer to lead systems engineering across the Spectris AD product development lifecycle, from requirements definition through commercialization and post-market support. Reporting to the Senior Vice President of Software Engineering, the Senior Systems Engineer is a cross-functional engineering leader responsible for aligning patient and clinician workflows, product functionality, quality, reliability, serviceability, manufacturability, regulatory compliance, and cost objectives across the therapy delivery modality (headset), the companion app, and the supporting software systems that together deliver Spectris AD.\nCore responsibilities include requirements definition and flow-down, system architecture and design, integration, modeling, risk management, design verification and validation, reliability assessment, manufacturing support, and resolution of field issues. The Senior Systems Engineer applies systems engineering principles to translate clinical, patient, and caregiver needs into product solutions through design trade-off analyses, integration, and verification.\nThe position shapes engineering approaches, projects, and programs across Cognito, driving improvements in product quality, team effectiveness, and operational efficiency. The role calls for deep technical expertise, sound judgment, the ability to coach and influence cross-functional colleagues, and substantial input into priorities, processes, and technical decisions at a company preparing for FDA authorization and commercial launch.\nResponsibilities\nLeads systems engineering activities for Spectris AD across the medical device development lifecycle, from concept through commercialization and post-market support.\nOwns the definition, development, and delivery of product features and clinical applications, including requirements management, architecture development, design analysis, integration, verification, validation, and risk management.\nDrives technical risk identification and retirement while ensuring compliance with applicable quality, regulatory, cybersecurity, and safety requirements.\nLeads cross-functional development teams spanning engineering, clinical, quality, regulatory, product management, manufacturing, service, and commercial organizations.\nEnsures requirements flow-down and traceability from patient, caregiver, and clinician needs through system, subsystem, and component level specifications.\nConducts system design trade-off analyses and makes evidence-based decisions that balance performance, reliability, manufacturability, serviceability, scalability, and cost objectives.\nLeads design control activities including failure modes and effects analysis (FMEA), hazard analysis, design verification and validation planning, reliability testing, defect prevention, and corrective and preventive actions (CAPAs).\nServes as the primary systems engineering representative for internal and external audits, regulatory submissions including the De Novo submission, design reviews, and compliance activities.\nProvides technical leadership and mentoring to engineering teams, shaping program priorities, development strategies, and execution plans across multiple product generations.\nCollaborates with internal teams and external development and manufacturing partners to resolve complex technical challenges, manage dependencies across subsystems, and ensure the components of Spectris AD integrate into a single coherent service.\nSupports manufacturing, field service, and patient support escalations, driving root cause analysis and continuous product improvement.\nQualifications\nBS in engineering, computer science, biomedical engineering, electrical engineering, mechanical engineering, or a related technical discipline; an advanced degree is a plus but not required.\nMinimum of 8 years of engineering experience in product development.\nMinimum of 6 years of experience with systems engineering, product development, and design control processes within medical device, healthcare technology, or another highly regulated industry.\nDemonstrated command of the product development lifecycle, requirements management, risk management, design verification and validation, and regulatory compliance.\nExperience leading cross-functional product development teams and complex technical programs.\nKnowledge of system architecture, subsystem integration, and the interaction of software and hardware.\nWorking knowledge of FDA design controls (21 CFR 820), ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, and IEC 62366-1.\nExpertise in failure modes and effects analysis (FMEA), reliability engineering, and Quality Management System (QMS) practices.\nExperience supporting regulatory submissions, audits, or inspections is a plus but not required.\nExperience with neurotechnology, wearable or home use medical devices, or connected device and companion application architectures is a plus but not required.\nExperience leading new product introductions and multi-generational product development programs is a plus but not required.\nStrong analytical, problem solving, communication, and stakeholder management skills.\nProven ability to lead and influence technical strategy, mentor engineers, and drive execution across teams without formal authority.\nComfort operating in a fast-paced, dynamic environment with evolving priorities.\nCompetitive Benefits\nTaking care of our own is one of our highest priorities. That’s why we offer benefits including unlimited PTO, wellness perks, virtual medical support, and health, dental, and vision insurance.\nPhysical Requirements & Work Environment\nThis role is primarily performed in an office or home-office setting. Essential physical requirements include the ability to work at a computer for extended periods, communicating effectively in written and verbal formats, and participate in video and in-person meetings.\nOccasional travel to partner sites may be required. For remote roles, occasional travel to Cognito’s Cambridge, MA office may also be required.\nCognito Therapeutics is committed to providing reasonable accommodation for qualified individuals with disabilities throughout the application and hiring process. If you require accommodation, please contact us at .\nCognito Therapeutics is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and make employment decisions based on qualifications, merit, business needs, and job requirements. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.\nAll applicants must be legally authorized to work in the United States.","description_format":"text","description_chars":8202,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Unlimited PTO","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Drug Discovery","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-20T15:22:06Z"}],"visa":[],"liveness":{"score":72,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.8,"p_room":0.9,"age_days":15,"expected_fill_days":36,"reasons":["conf:2","win:mid"],"computed_at":"2026-10-29T05:49:05Z"},"pay":null,"html_url":"https://alion.io/job/cognito-therapeutics-inc-senior-systems-engineer","json_url":"https://alion.io/job/cognito-therapeutics-inc-senior-systems-engineer.json","meta":{"generated_at":"2026-10-29T12:58:23Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":19535,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2151697},"rest":"https://alion.io/mcp/rest/get_company?id=2151697"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcognito-therapeutics-inc-senior-systems-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fcognito-therapeutics-inc-senior-systems-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fcognito-therapeutics-inc-senior-systems-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/cognito-therapeutics-inc-senior-systems-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcognito-therapeutics-inc-senior-systems-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2933399}},{"tool":"search_jobs","arguments":{"company":"cognitotx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2933399},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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