{"id":594109,"url":"https://alion.io/job/synchron-senior-quality-engineer-new-product-dev-ca","title":"Senior Quality Engineer-New Product Dev- CA","company":{"id":63210,"name":"Synchron","domain":"synchron.com","url":"https://alion.io/company/synchron","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","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":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":130000,"max":150000,"currency":"USD","period":"year","gross":null,"usd_annual":150000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[],"status":"live","first_seen_at":"2026-07-08T18:30:00Z","employer_posted_date":"2026-07-08","last_verified_at":"2026-10-18T08:16:55Z","board_verified":true,"closed_at":null,"days_open":101,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":101},"description":"About Synchron\nSynchron’s vision is to build non-surgical brain-computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems.\nSenior Quality Engineer (New Product Development)\nQuality\nLocation: San Diego, CA (On-site)***Please note must be located within commuting distance of San Diego, CA. ***\nEmployment Type: Full-Time\nAbout the Role\nAs Senior Quality Engineer (New Product Development), you will serve as the Quality lead across Synchron’s product development programs, partnering with R&D, Systems Engineering, Clinical, Regulatory Affairs, Manufacturing Engineering, and Operations to ensure quality is built into products from concept through commercialization. You will lead Design Quality activities, ensure compliance with FDA, ISO 13485, ISO 14971, and applicable international regulations, and facilitate successful transfer of new products into manufacturing. You will also provide operational quality support during pilot builds and early production while contributing to the development and continuous improvement of Synchron’s Quality Management System.\nKey Responsibilities\nDesign Quality & New Product Development\nServe as the Quality representative on cross-functional product development teams from concept through commercialization.\nEnsure compliance with Design Controls in accordance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulations.\nLead Design Quality deliverables including:Design Reviews\nDesign Verification & Validation (V&V)\nDesign History File (DHF) development\nTraceability\nEngineering Change Assessments\n\nFacilitate product risk management activities in accordance with ISO 14971, including hazard analyses, risk assessments, FMEAs, and verification of risk controls.\nReview and approve product requirements, specifications, protocols, reports, drawings, and engineering documentation to ensure quality and regulatory compliance.\nCollaborate with engineering teams to establish critical quality attributes, acceptance criteria, and design inputs/outputs.\nDrive Design for Manufacturability (DFM), Design for Assembly (DFA), Design for Reliability (DFR), and Design for Quality (DFQ) principles throughout development.\nUp to 20% travel expected, primarily for contract manufacturer visits and supplier audits.\nDesign Transfer & Manufacturing Readiness\nPartner with R&D and Manufacturing Engineering to execute successful design transfer into production.\nDevelop manufacturing quality strategies including Process FMEAs, Control Plans, inspection strategies, and manufacturing quality gates.\nSupport process validation activities (IQ/OQ/PQ), equipment qualification, and pilot manufacturing builds.\nEvaluate manufacturing readiness and identify quality risks prior to product launch.\nSupport engineering changes through impact assessments and change control activities.\nOperations & Supplier Quality\nCollaborate with Operations and Supplier Quality to qualify suppliers and contract manufacturers supporting new product development.\nReview supplier validation activities, incoming inspection strategies, and quality documentation.\nSupport investigations involving nonconforming materials, manufacturing deviations, and CAPAs associated with prototype and pilot production.\nMonitor quality metrics during new product introduction (NPI) and drive continuous improvement initiatives.\nQuality Systems & Regulatory Support\nAuthor and maintain Design Quality documentation including:Design Plans\nDHFs\nRisk Management Files\nSOPs\nQuality Plans\nVerification & Validation protocols and reports\n\nSupport Regulatory Affairs during submissions by ensuring quality documentation is complete and inspection-ready.\nParticipate in internal audits, supplier audits, FDA inspections, and Notified Body audits.\nContribute to continuous improvement of Synchron’s Quality Management System.\nRequired Qualifications\nBachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related technical/science field\n7+ years of Quality Engineering experience in an FDA-regulated medical device environment with demonstrated experience supporting new product development, design controls, risk management, verification & validation, and design transfer.\nExperience supporting Class III medical devices preferred.CERTIFICATIONS\nPreferred Qualifications\nISO 13485:2016 Lead Auditor Certification (or willingness to obtain); CQE or CQA preferred .\nDemonstrated knowledge of FDA Design Controls and product development processes.\nStrong understanding of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and applicable product standards.\nExperience with Design Verification, Validation, Design Reviews, Design History Files, and traceability.\nExperience performing Design and Process FMEAs and applying risk management principles.\nKnowledge of process validation (IQ/OQ/PQ), manufacturing process development, and design transfer.\nFamiliarity with supplier quality management and contract manufacturing.\nAbility to interpret engineering drawings, GD&T, and product specifications.\nStrong technical writing and documentation skills.\nExcellent communication and collaboration skills within multidisciplinary development teams.\nAbility to balance innovation with regulatory compliance in a fast-paced product development environment.\nCompensation\nThe base salary range for this role is $130,000 - $150,000 depending on experience, skills, and qualifications.\nIn addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants, subject to board approval and company policy.\nVisa Sponsorship\nWe are unable to offer visa sponsorship for this position currently.\nBenefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible\nSubsidized medical and dental insurance coverage for you and your dependent(s) \nLife insurance, short-term disability, long-term disability \n401k \nDiscretionary unlimited PTO \nFlexible Spending Account for you and your dependent(s), with eligible plan elections\nCommuter benefits for NY employees\nEqual Employment Opportunity (EEO)\nSynchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law.\nIf you need a reasonable accommodation during the application or interview process, please let us know.\nJoin Us\nAt Synchron, you will be part of a transformative mission, and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.","description_format":"text","description_chars":7580,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Dental insurance","Equity","Insurance coverage","Life insurance","Unlimited PTO"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-09-10T14:50:50Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1 · green card filings: 2","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":2,"median_offered_wage_usd":149167,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":13,"band":"cold","label":"Long shot","p_open":1,"p_active":0.469,"p_room":0.28,"age_days":100,"expected_fill_days":36,"reasons":["conf:3","win:tail","crowd:"],"computed_at":"2026-10-17T05:46:00Z"},"pay":{"stated_usd_annual":150000,"is_top_pay":true},"html_url":"https://alion.io/job/synchron-senior-quality-engineer-new-product-dev-ca","json_url":"https://alion.io/job/synchron-senior-quality-engineer-new-product-dev-ca.json","meta":{"generated_at":"2026-10-18T11:38:14Z","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":17266,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-19T00:00:00Z"}},"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":63210},"rest":"https://alion.io/mcp/rest/get_company?id=63210"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsynchron-senior-quality-engineer-new-product-dev-ca"},{"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%2Fsynchron-senior-quality-engineer-new-product-dev-ca"},{"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%2Fsynchron-senior-quality-engineer-new-product-dev-ca"},{"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/synchron-senior-quality-engineer-new-product-dev-ca\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsynchron-senior-quality-engineer-new-product-dev-ca"}]}