{"id":1938413,"url":"https://alion.io/job/capstan-medical-supplier-development-engineer","title":"Supplier Development Engineer","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":68,"open_postings":19,"ghost_share":0.526,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-09T06:01:00Z"}},"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 Cruz, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":84000,"max_usd":162000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4338},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-28T18:19:27Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-10-09T23:48:41Z","board_verified":true,"closed_at":null,"days_open":11,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":9},"description":"The Supplier Development Engineer (SDE) is responsible for developing, qualifying, monitoring, and improving supplier performance to ensure the consistent delivery of high-quality materials, components, and services. This role serves as a key liaison between suppliers and internal teams to drive quality, delivery, cost, and process improvements while ensuring compliance with applicable regulatory and quality management system requirements, including ISO 13485 and customer-specific requirements.\nThe SDE will lead supplier qualification activities, Process Validation efforts, Production Part Approval Process (PPAP) submissions, supplier audits, corrective actions, and continuous improvement initiatives to support both new product development and ongoing production.\nEssential Responsibilities\nSupplier Quality Management\nLead supplier selection, qualification, onboarding, and performance management activities.\nConduct supplier audits and assessments to evaluate manufacturing capabilities, process controls, and quality management systems.\nDevelop supplier improvement plans and monitor progress against established metrics.\nEstablish and maintain supplier scorecards for quality, delivery, responsiveness, and cost performance.\nSupport supplier risk assessments and mitigation activities.\nPPAP & Process Validation\nLead and review Production Part Approval Process (PPAP) submissions for new and existing suppliers.\nReview and approve key PPAP documentation including:\nProcess Flow Diagrams\nPFMEA (Process Failure Mode and Effects Analysis)\nControl Plans\nMeasurement System Analysis (MSA)\nCapability Studies (Cp/Cpk)\nFirst Article Inspection Reports (FAIR)\nDimensional Results\nMaterial Certifications\nEnsure process validations and manufacturing controls are implemented and maintained by suppliers.\nCollaborate with suppliers to resolve PPAP deficiencies and qualification issues.\nQuality Assurance & Compliance\nEnsure supplier compliance with ISO 13485 requirements and applicable regulatory standards.\nSupport supplier quality activities associated with medical device manufacturing and applicable regulatory requirements.\nParticipate in internal and external audits as subject matter expert for supplier quality processes.\nEnsure supplier documentation, records, and quality systems meet company and regulatory expectations.\nSupport change control activities including supplier process changes, material changes, and manufacturing transfers.\nCorrective and Preventive Actions\nLead root cause investigations using methodologies such as:\n8D\n5 Why\nFishbone Analysis\nFault Tree Analysis\nDrive supplier corrective and preventive action (CAPA) effectiveness.\nVerify implementation and sustainability of corrective actions.\nEscalate recurring supplier quality issues as appropriate.\nContinuous Improvement\nIdentify and implement supplier process improvements that enhance quality, reliability, capacity, and cost.\nUtilize Lean Manufacturing and Six Sigma tools to drive continuous improvement initiatives.\nCollaborate with Engineering, Operations, Procurement, and Quality teams to reduce risk and improve supplier performance.\nSupport cost reduction and value engineering initiatives.\nRequired Qualifications\nEducation\nBachelor's degree in Engineering, Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, or related technical discipline.\nExperience\n5+ years of experience in Supplier Quality Engineering, Supplier Development, Manufacturing Engineering, Quality Engineering, or related field.\nExperience working within regulated manufacturing environments.\nDemonstrated experience with PPAP, APQP, PFMEA, Control Plans, and MSA.\nExperience conducting supplier audits and managing supplier corrective actions.\nExperience working with ISO 13485 quality management systems.\nStrong understanding of manufacturing processes including machining, molding, assembly, electronics, metals, plastics, or medical device manufacturing.\nTechnical Skills\nWorking knowledge of:\nPPAP\nAPQP\nPFMEA\nSPC\nMSA\nControl Plans\nGD&T\nRoot Cause Analysis\nCAPA Systems\nProficiency with quality tools and statistical analysis methods.\nAbility to interpret engineering drawings, specifications, and technical standards.\nExperience using ERP, PLM, and quality management systems.\nPreferred Qualifications\nASQ Certified Supplier Quality Engineer (CSQE), Certified Quality Engineer (CQE), or equivalent certification.\nLead Auditor certification for ISO 13485 or ISO 9001.\nSix Sigma Green Belt or Black Belt certification.\nExperience supporting FDA-regulated medical device manufacturing environments.","description_format":"text","description_chars":4616,"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","Medical AI"],"lifecycle":[{"event":"open","at":"2026-10-06T00:59:15Z"}],"visa":[],"liveness":{"score":49,"band":"ok","label":"Likely open","p_open":1,"p_active":0.545,"p_room":0.9,"age_days":10,"expected_fill_days":22,"reasons":["conf:1","stale_co","win:mid"],"computed_at":"2026-10-09T06:01:00Z"},"pay":null,"html_url":"https://alion.io/job/capstan-medical-supplier-development-engineer","json_url":"https://alion.io/job/capstan-medical-supplier-development-engineer.json","meta":{"generated_at":"2026-10-10T00:53:31Z","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","counted_by":"address","units_charged":1,"used_today":1408,"day_limit":5000,"remaining_today":3592,"minute_limit":60,"resets_at":"2026-10-11T00:00:00Z"}},"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-supplier-development-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%2Fcapstan-medical-supplier-development-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%2Fcapstan-medical-supplier-development-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/capstan-medical-supplier-development-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcapstan-medical-supplier-development-engineer"}]}