{"id":4043587,"url":"https://alion.io/job/arthrex-senior-engineer-qa-design-arthroscopy","title":"Senior Engineer, QA Design - Arthroscopy","company":{"id":12664,"name":"Arthrex","domain":"arthrex.com","url":"https://alion.io/company/arthrex","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":{"grade":"A","score":94,"open_postings":16,"ghost_share":0,"stale_share":0.188,"repost_share":0.063,"time_to_fill_p50_days":24,"computed_at":"2026-11-10T06:52:35Z"}},"role":"QA","role_family":"QA","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Naples, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"GD&T","optional":false},{"name":"Human Factors Engineering","optional":false},{"name":"IEC 62366","optional":false},{"name":"ISO 14971","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-11-06T00:00:00Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-10T23:02:49Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Engineer, Design Quality for our global headquarters in Naples, FL.The Senior Engineer QA Design is responsible for interfacing and driving Design Assurance principles within engineering teams for design, development transfer and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.\nEssential Duties and Responsibilities:\nLead design assurance efforts within product design and development for new product introduction projects with an emphasis in quality aspects of integrated software, electrical, and/or mechanical device characteristics, as appropriate for the specific area of position focus.\nEnsure appropriateness of documented design requirements and outputs while ensuring traceability throughout the product development lifecycle.\nProvide active leadership in understanding and implementing regulations/standards, acting as a resource to other disciplines, within the product design process from idealization through product retirement.\nSupervise, assign, and coordinate others / the work of others within the design assurance team to support the department and design projects and goals.\nProvide input into and lead addressing of lessons learned to support development, modification, and improvement of design processes and quality management system.\nLead product risk assessment activities through application of a working knowledge of applicable standards (e.g., ISO14971, etc.) and tools such as (application, design, process) FMEAs, FTA, and Hazard Assessment.\nDisplay working knowledge and provide guidance to design teams in the area of usability/human factors engineering principles including standards (IEC 62366) and FDA guidance for compliance.\nFacilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process.\nLead and coordinate the design assurance aspects of Design to Manufacture Transfer including generation of inspection methods, drawing reviews, determining key product indicators/essential requirements and, where appropriate, training of manufacturing personnel in appropriate test procedures, inspection methods, and interpretation of results.\nEnsure required outputs of the design control process are met, including compliance of the design history file (DHF), and support transition of the design project into sustaining engineering.\nSupport design-related corrective and preventative activities for projects in the pre-sustaining phase. \nEducation and Experience:\nBachelor’s degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering degree preferred.\n5 years design assurance / quality assurance experience in a medical device or other highly regulated industry required.\nKnowledge and Skill Requirements/Specialized Courses and/or Training:\nWorking knowledge of ISO and FDA design and development quality requirements.\nTechnical knowledge in development methodologies, design quality analysis, and project implementation.\nProficiency in assessing manufacturing quality requirements of new product concepts.\nTechnical knowledge in development methodologies, design, and project implementation, including but not limited to, GD&T & DOE preferred.\nMachine, Tools, and/or Equipment Skills:\nProficiency with PC operations, and the Microsoft Office suite, and CAD/CAM Software. Hands on experience with SAP and Agile preferred.\nReasoning Ability:\nAbility to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.\nMathematical Skills\nAbility to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.\nLanguage and Communication Skills:\nAbility to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.","description_format":"text","description_chars":4484,"description_truncated":false,"requirements":{"experience_years_min":null,"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":["Surgical Instruments & Devices","Orthopedic & Spine Implants","Medical Education & Training"],"lifecycle":[{"event":"open","at":"2026-11-10T23:02:49Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 19 · green card filings: 2","filings_12m":19,"filings_prev_12m":27,"green_card_filings_12m":2,"median_offered_wage_usd":167500,"route":null,"cap_exempt":false,"checked_at":"2026-11-10T11:34:35+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":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":5,"expected_fill_days":24,"reasons":["conf:2","win:early","comp:brand"],"computed_at":"2026-11-11T01:35:58Z"},"pay":null,"html_url":"https://alion.io/job/arthrex-senior-engineer-qa-design-arthroscopy","json_url":"https://alion.io/job/arthrex-senior-engineer-qa-design-arthroscopy.json","meta":{"generated_at":"2026-11-11T01:35:58Z","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":1165,"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":12664},"rest":"https://alion.io/mcp/rest/get_company?id=12664"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Farthrex-senior-engineer-qa-design-arthroscopy"},{"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%2Farthrex-senior-engineer-qa-design-arthroscopy"},{"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%2Farthrex-senior-engineer-qa-design-arthroscopy"},{"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/arthrex-senior-engineer-qa-design-arthroscopy\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Farthrex-senior-engineer-qa-design-arthroscopy"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4043587}},{"tool":"search_jobs","arguments":{"company":"arthrex.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4043587},"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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