{"id":1182039,"url":"https://alion.io/job/arthrex-engineer-senior-i-qa-design-electromechanical","title":"Engineer Senior I - QA Design (Electromechanical)","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":100,"open_postings":9,"ghost_share":0,"stale_share":0.111,"repost_share":0,"time_to_fill_p50_days":20,"computed_at":"2026-10-17T05:46:00Z"}},"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":["Santa Barbara, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":73000,"max_usd":142000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":550},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-16T00:00:00Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-10-18T23:21:21Z","board_verified":true,"closed_at":null,"days_open":33,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":33},"description":"Location:\nSanta Barbara, CA\n\nER Bonus:\n$2,500.00\n\nSalary Range:\n\nSalary Minimum:\n$109,250.00\n\nSalary Maximum:\n$178,435.00\n\nArthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer, Sr. I - QA Design who 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™.\n\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.\nFor electrical equipment / active device projects, lead compliance efforts for electrical safety, environmental, and emissions in accordance with national and international regulations.\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.\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.\nBasic knowledge in Electro-Medical safety standards - IEC 60601-1 (Electrical safety), IEC 60601-1-2 (EMC), and other Collateral and Particular standards.\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, Codebeamer and Windchill 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.\nArthrex Benefits\nMedical, Dental and Vision Insurance\nCompany-Provided Life Insurance\nVoluntary Life Insurance\nFlexible Spending Account (FSA)\nSupplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)\nMatching 401(k) Retirement Plan\nAnnual Bonus\nWellness Incentive Program\nFree Onsite Lunch\nGym Reimbursement Program\nTuition Reimbursement Program\nTrip of a Lifetime\nPaid Parental Leave\nPaid Time Off\nPaid Sick Leave\nVolunteer PTO\nEmployee Assistance Provider (EAP)\nAll qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.","description_format":"text","description_chars":5473,"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":["Life insurance","Parental leave","Retirement plans","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants"],"lifecycle":[{"event":"open","at":"2026-09-24T14:26:19Z"}],"visa":[{"country":"US","licensed_sponsor":true,"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":"2026-10-15T11:24:14+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":31,"band":"fade","label":"Fading","p_open":1,"p_active":0.69,"p_room":0.45,"age_days":31,"expected_fill_days":20,"reasons":["conf:14","velocity","win:tail","comp:brand"],"computed_at":"2026-10-17T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/arthrex-engineer-senior-i-qa-design-electromechanical","json_url":"https://alion.io/job/arthrex-engineer-senior-i-qa-design-electromechanical.json","meta":{"generated_at":"2026-10-19T01:34:32Z","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":940,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-20T00:00:00Z"}},"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":12664},"rest":"https://alion.io/mcp/rest/get_company?id=12664"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Farthrex-engineer-senior-i-qa-design-electromechanical"},{"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%2Farthrex-engineer-senior-i-qa-design-electromechanical"},{"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%2Farthrex-engineer-senior-i-qa-design-electromechanical"},{"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-engineer-senior-i-qa-design-electromechanical\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Farthrex-engineer-senior-i-qa-design-electromechanical"}]}