{"id":458825,"url":"https://alion.io/job/capstan-medical-design-quality-engineer-robot","title":"Design Quality Engineer - Robot","company":{"id":176338,"name":"Capstan Medical","domain":"capstanmedical.com","url":"https://alion.io/company/capstan-medical","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"C","score":62,"open_postings":22,"ghost_share":0.636,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-11-05T05:54:30Z"}},"role":"MedTech","role_family":"MedTech","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 Cruz, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":102000,"max_usd":190000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":50},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"FMEA","optional":false},{"name":"Ion Implantation","optional":false},{"name":"ISO 13485","optional":false},{"name":"Verification & Validation","optional":false},{"name":"IEC 60601","optional":true},{"name":"ISO 14971","optional":true}],"status":"live","first_seen_at":"2026-07-16T13:54:52Z","employer_posted_date":"2026-07-16","last_verified_at":"2026-11-06T03:39:11Z","board_verified":true,"closed_at":null,"days_open":112,"trust":{"level":"ghost","repost_count":0,"flags":["stale","company_stale"],"days_open":111},"description":"At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech-developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical robotics, catheter-based delivery, and next-generation implants to transform complex procedures into safer, lower-stress solutions for patients and clinicians alike. As a highly collaborative, hands-on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone.\nBased in Santa Cruz, our unique workspace blends cutting-edge Bay Area innovation with a lifestyle-driven environment near trails, beaches, and open space-creating the perfect place to do meaningful, career-defining work.\nReports to: Quality Manager\nWorkplace type: Onsitein Santa Cruz, CA\nThe Opportunity:\nAs a Design Quality Engineer, you will provide design quality support for the company’s design control activities, with a primary focus on the development of the surgical robot. You will partner with the R&D, regulatory, and clinical development engineering teams to ensure that our cardiovascular robotic platform is designed for safety, reliability, and manufacturability.\nWhat you’ll do:\nSupport the execution of design control activities, ensuring compliance with ISO 13485 and FDA 21 CFR 820.30 throughout the Product Development Process.\n\nSupport creation of Risk Management Files, including the development of Design FMEA and Use FMEA.\n\nReview and approve Design Verification and Validation protocols, test methods, and reports to ensure devices meet all functional, clinical, and standards-based requirements.\n\nParticipate in design reviews, providing critical feedback on design controls and risk mitigation.\n\nReview and maintain Design History File documentation and ensure compliance to internal processes and external standards and regulations.\n\nChampion the quality system and identify continuous improvement opportunities\n\nSupport internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings\n\nDrive nonconforming material investigations and implementation of effective CAPAs\n\nEnsure compliance with relevant regulatory requirements, such as FDA QMSR and ISO 13485 standards.\n\nWhat you’ll need:\nBachelor's degree in Engineering or a related technical field. Master's degree is a plus.\n\nMinimum of 5 years of experience in a design quality assurance/engineering role within the medical device industry supporting electromechanical capital devices.\n\nIn-depth knowledge of design controls (21 CFR 820.30), risk management (ISO 14971), quality management systems (ISO 13485), basic safety and essential performance of medical electrical equipment (IEC 60601-1), and other relevant quality & safety standards for robotic medical devices.\n\nAbility to support multiple concurrent design control activities in a fast-paced startup environment\n\nStrong documentation, organizational, and communication skills.\n\nWays to stand out from the crowd:\nExperience supporting development of surgical robotic devices.\n\nCertifications such as Six Sigma and ASQ Certified Quality Engineer (CQE).\n\nExcellent problem-solving skills and ability to apply root cause analysis methodologies.\n\nDetail-oriented with effective organizational and documentation skills.\n\nWhy join us:\nWe offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.\n\nWe offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.\n\nWe thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!","description_format":"text","description_chars":3813,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical & Healthcare Robotics","Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-09-06T10:20:40Z"}],"visa":[],"liveness":{"score":8,"band":"cold","label":"Long shot","p_open":1,"p_active":0.278,"p_room":0.28,"age_days":111,"expected_fill_days":29,"reasons":["conf:2","stale_co","ghost","win:tail","crowd:"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/capstan-medical-design-quality-engineer-robot","json_url":"https://alion.io/job/capstan-medical-design-quality-engineer-robot.json","meta":{"generated_at":"2026-11-06T04:30:14Z","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":7675,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":176338},"rest":"https://alion.io/mcp/rest/get_company?id=176338"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcapstan-medical-design-quality-engineer-robot"},{"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%2Fcapstan-medical-design-quality-engineer-robot"},{"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%2Fcapstan-medical-design-quality-engineer-robot"},{"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/capstan-medical-design-quality-engineer-robot\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcapstan-medical-design-quality-engineer-robot"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":458825}},{"tool":"search_jobs","arguments":{"company":"capstanmedical.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":458825},"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. Docs: https://alion.io/developers"}}