{"id":1644052,"url":"https://alion.io/job/atricure-principal-quality-operations-engineer","title":"Principal Quality Operations Engineer","company":{"id":2273800,"name":"Atricure","domain":"atricure.com","url":"https://alion.io/company/atricure","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":95,"open_postings":4,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":84,"computed_at":"2026-10-15T05:46:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mason, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":87000,"max_usd":178000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1695},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-07-24T15:06:51Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-15T12:07:36Z","board_verified":true,"closed_at":null,"days_open":82,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":82},"description":"AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.\nWe foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.\nPOSITION SUMMARY:\nThe Principal Quality Operations Engineer provides enterprise technical leadership and quality oversight for the manufacturing infrastructure, critical facility systems, and utility systems that support compliant, reliable production. This position is accountable for defining the quality strategy, governance, and lifecycle expectations for these systems, including risk assessment, system and process validation, change control, program management, and continuous improvement. This includes ownership of the policies, procedures, controls, and quality practices that govern these systems. The role serves as a senior technical authority and trusted advisor, influencing cross-functional decisions to ensure facility and utility systems remain capable, controlled, inspection-ready, and aligned with applicable regulatory requirements and the AtriCure Quality Management System.\nESSENTIAL FUNCTIONS OF THE POSITION:\nLead the risk management program for critical facility and utility systems, including risk governance, escalation, timely investigation, and implementation of mitigations for identified risks, excursions, and quality issues.\nDefine quality documentation expectations for facility and utility systems, including user needs, requirements, drawings, specifications, risk documentation, validation evidence, process controls, and related records.\nEstablish quality strategies, Quality Plans, and validation master plans to guide large facility updates, utility changes, and critical system lifecycle management in alignment with AtriCure validation and quality system policies.\nLead strategic quality and facility implementation programs from initiation through completion, including priorities, deliverables, resource alignment, stakeholder engagement, risk-based decision-making, and executive-level status communication.\nAdvise cross-functional teams on facility change requests, including line moves, equipment moves, utility additions, and related changes that support production operations and require quality impact assessment.\nProvide technical authority for qualification and validation strategies applied to critical facility, utility, equipment, monitoring, and data systems, including development, execution, review, and approval of IQ/OQ/PQ documentation and lifecycle activities.\nLead validation and data integrity practices for systems that capture critical facility and utility data, including dashboards, alert and action limits, trend monitoring, and escalation of conditions requiring investigation or corrective action.\nDrive development and improvement of quality system procedures and program controls governing critical facility and utility systems and supporting Quality Operations programs.\nChampion continuous improvement opportunities that increase efficiency, capacity, reliability, compliance, and operational readiness of critical facility and utility systems.\nServe as a senior quality and engineering resource for facilities management, equipment qualification, process validation, preventive maintenance, and calibration activities related to Quality Operations-owned equipment.\nInfluence Facilities, Quality Management, Operations, and other departments to assess system capacity, support company strategies, resolve complex issues, and maintain alignment with business and quality objectives.\nDefine and communicate metrics that assess the health, performance, capacity, and compliance status of critical facility and utility systems, including status updates to quality, operational, and leadership forums.\nRepresent Quality Operations during internal and external audits, including preparation, response, and follow-up activities related to critical facility and utility systems.\nMentor Quality Operations engineers, build technical capability across the team, and provide trusted partnership and guidance to key stakeholders.\nLead with expert knowledge of prescribed GMP, ISO, and GLP standards and ensure compliance with applicable domestic and international regulations, standards, and controls relevant to risk management, process validation, environmental monitoring, and related areas.\nADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:\nRegular and predictable work performance\nAbility to work under fast-paced conditions\nAbility to make decisions and use good judgment\nAbility to prioritize various duties and multitask as required\nAbility to successfully work with others\nAdditional duties as assigned\nBASIC QUALIFICATIONS:\nBachelor’s degree in engineering, or an equivalent combination of education, training, and experience.\nMinimum of 10 years of experience in the Medical Device Manufacturing Experience, or Manufacturing production and process control experience within a regulated industry.\nExperience with facility, utility, equipment, and/or process validation in a regulated manufacturing environment, preferably medical device manufacturing.\nWorking knowledge of production and process controls, ISO 13485, GMP requirements, quality system procedures, and applicable validation standards and practices.\nAbility to develop and implement quality system programs, policies, procedures, technical documentation, validation master plans, and related controls.\nDemonstrated ability to lead cross-functional teams, influence alignment, facilitate decisions, and resolve complex technical and quality issues.\nStrong verbal, written, and presentation skills, including technical protocol and report development, stakeholder communication, and project status reporting.\nAbility to read and interpret technical specifications, blueprints, drawings, and related facility or engineering documentation.\nStrong problem-solving, troubleshooting, attention to detail, compliance orientation, and results-driven execution.\nProficiency with computer-based systems, data entry, and basic data analysis or statistical tools.\nAbility to travel up to 15%.\nPREFERRED QUALIFICATIONS:\nExperience in medical device manufacturing, quality operations, or quality management, preferably supporting sterile medical devices.\nKnowledge of cleanroom validation, contamination control, environmental monitoring, pest control, and facility-related safety practices.\nFacility engineering, facility design, construction, or manufacturing infrastructure experience in a regulated environment.\nProject management experience; PMP certification preferred.\nTechnical file or CAD drawing management experience.\nFDA, ISO, or other regulatory audit experience.\nASQ Certified Quality Engineer and/or ASQ Certified Six Sigma Black Belt certification.\nOTHER REQUIREMENTS:\nAbility to regularly walk, sit, or stand as needed\nAbility to occasionally bend and push/pull as needed\nAbility to regularly lift up to 25 pounds, occasionally lift over 25 pounds\nAbility to pass pre-employment drug screen and background check\nAtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits.\nAtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).\nYou may access our global privacy policy here: https://www.atricure.com/privacy","description_format":"text","description_chars":9354,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Cafeteria","Parental leave"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Surgical Instruments & Devices","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-10-01T22:56:44Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 10 · green card filings: 2","filings_12m":10,"filings_prev_12m":9,"green_card_filings_12m":2,"median_offered_wage_usd":126667,"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},{"country":"GB","licensed_sponsor":true,"evidence":"Licensed UK visa sponsor (Skilled Worker, Senior or Specialist Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Skilled Worker; Global Business Mobility: Senior or Specialist Worker","cap_exempt":false,"checked_at":"2026-10-15T06:21:15+00:00","sources":["UK Home Office: register of licensed sponsors (workers)"],"filings_for_role_12m":0}],"liveness":{"score":44,"band":"fade","label":"Fading","p_open":1,"p_active":0.737,"p_room":0.6,"age_days":82,"expected_fill_days":84,"reasons":["conf:1","win:late","crowd:"],"computed_at":"2026-10-15T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/atricure-principal-quality-operations-engineer","json_url":"https://alion.io/job/atricure-principal-quality-operations-engineer.json","meta":{"generated_at":"2026-10-15T13:18:12Z","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":20524,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-16T00:00:00Z"}},"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":2273800},"rest":"https://alion.io/mcp/rest/get_company?id=2273800"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fatricure-principal-quality-operations-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%2Fatricure-principal-quality-operations-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%2Fatricure-principal-quality-operations-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/atricure-principal-quality-operations-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fatricure-principal-quality-operations-engineer"}]}