{"id":710865,"url":"https://alion.io/job/epianeuro-senior-quality-engineer","title":"Senior Quality Engineer","company":{"id":673459,"name":"Epia Neuro","domain":"epianeuro.com","url":"https://alion.io/company/epianeuro","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":{"grade":"A","score":95,"open_postings":11,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":70,"computed_at":"2026-11-11T05:49:22Z"}},"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":["Alameda, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":115000,"max":150000,"currency":"USD","period":"year","gross":null,"usd_annual":150000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Human Factors Engineering","optional":true},{"name":"IEC 62366","optional":true},{"name":"Machine Learning","optional":true},{"name":"SBOM","optional":true}],"status":"live","first_seen_at":"2026-08-05T18:26:12Z","employer_posted_date":"2026-08-05","last_verified_at":"2026-11-11T11:47:16Z","board_verified":true,"closed_at":null,"days_open":97,"trust":{"level":"ok","repost_count":0,"flags":[],"days_open":97},"description":"About Us\nEpia Neuro is a neural technology company developing intent-driven systems designed to restore function and independence for people living with neurological conditions. Its platform integrates implantable neural interfaces, adaptive algorithms, and assistive devices to translate neural intent into real-world action. The company's initial focus is stroke-related motor impairment, with expansion in cognitive decline and other neurological disorders, focusing on long-term solutions for the growing aging population.\nThe Opportunity\nWe're building out our quality function from the ground up, and we're looking for a Senior Quality Engineer to help us do it. You'll bring hands-on software quality engineering experience to support our software and firmware teams in meeting IEC 62304, ISO 14971, and ISO 13485/FDA QMSR requirements throughout the product lifecycle.\nReporting to our Quality Manager, you'll contribute to design control reviews, help maintain the software risk management file, and support release and change control decisions. This is a role for someone who wants to help stand up a quality function early and grow into more independent authority as the function matures.\nKey Responsibilities\nFoundational Quality Processes: Help build and document core software quality processes including design control procedures, traceability practices, and review workflows that will scale with the company.\n\nDesign Controls & Risk Management: Contribute to design input/output reviews and verification/validation activities under ISO 13485/FDA QMSR; maintain the software contribution to the ISO 14971 risk management file, including hazard-to-requirement traceability.\n\nIEC 62304 Compliance: Review software development plans, lifecycle deliverables, and verification documentation against IEC 62304; working with software and firmware engineers, lead software safety classification based on risk.\n\nConfiguration Management & Change Control: Support source control and build reproducibility audits against regulatory requirements; assess engineering change requests for software safety, risk, and regulatory impact.\n\nSOUP & Cybersecurity: Own evaluation and qualification of third-party software, libraries, and vendors (SOUP); review premarket cybersecurity documentation for completeness.\n\nAI/ML Quality Support: Support quality review of ML model lifecycle documentation.\n\nAudits & CAPA: Support internal and FDA audits alongside our Quality Manager; contribute to root-cause analysis and CAPA for software defects.\n\nRequired Qualifications\nBachelor's degree required, preferred in a related field such as Biomedical Engineering, Computer Science/Software Engineering, Electrical Engineering, Systems Engineering, Quality Engineering, or Industrial Engineering.\n\n5+ years of experience in medical device software quality engineering, including hands-on work with IEC 62304 lifecycle deliverables for Class C software.\n\nWorking knowledge of ISO 13485 quality systems and design and development documentation.\n\nExperience contributing to risk management (ISO 14971) processes within the scope of medical device software.\n\nComfortable raising quality concerns directly with engineering teams and holding a position under pressure while partnering constructively to help identify and define appropriate solutions.\n\nPreferred Qualifications\nExperience with Class III or active implantable medical device products.\n\nFamiliarity with usability engineering (IEC 62366) documentation for medical device software.\n\nExposure to medical device cybersecurity documentation (FDA premarket expectations, SBOM).\n\nFamiliarity with AI/ML in medical devices (Good Machine Learning Practice principles)\n\nExposure to agile software development in a regulated context (AAMI TIR45).\n\nPrevious role at a fast-paced medical device startup.\n\nHow We Work\nWe are intentional. We prioritize and are thoughtful about how we use others' time.\n\nWe care for others. We prioritize safety both for patients and one another.\n\nWe own outcomes, not just tasks. Our work demands the highest standards because it impacts real patients and real lives.\n\nHumility is a strength. We are honest about what we know and what we don't know. Getting it right matters more than being right.\n\nBenefits\nFull-time employees are eligible for the following benefits:\nCompetitive base salary with equity\n\n100% of healthcare coverage for you and your dependents\n\nGenerous vacation policy\n\nPaid parental leave\n\nWork from our beautiful waterfront office in Alameda, CA, with access to collaborative spaces and labs.","description_format":"text","description_chars":4578,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Generous vacation","Parental leave"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Information Security","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-09-11T04:42:08Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 7","filings_12m":7,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":212500,"route":null,"cap_exempt":false,"checked_at":"2026-11-11T07:38:50+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":32,"band":"fade","label":"Fading","p_open":1,"p_active":0.728,"p_room":0.44,"age_days":97,"expected_fill_days":70,"reasons":["conf:3","win:tail","crowd:"],"computed_at":"2026-11-11T05:49:22Z"},"pay":{"stated_usd_annual":150000,"is_top_pay":true},"html_url":"https://alion.io/job/epianeuro-senior-quality-engineer","json_url":"https://alion.io/job/epianeuro-senior-quality-engineer.json","meta":{"generated_at":"2026-11-11T15:56:02Z","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":29819,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-12T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":673459},"rest":"https://alion.io/mcp/rest/get_company?id=673459"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fepianeuro-senior-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fepianeuro-senior-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fepianeuro-senior-quality-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/epianeuro-senior-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fepianeuro-senior-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":710865}},{"tool":"search_jobs","arguments":{"company":"epianeuro.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":710865},"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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