{"id":1644033,"url":"https://alion.io/job/atricure-quality-engineer","title":"Quality 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":"B","score":75,"open_postings":6,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-03T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","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":61000,"max_usd":116000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1752},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-08-18T19:27:52Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-04T00:08:39Z","board_verified":true,"closed_at":null,"days_open":46,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":46},"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 Quality Engineer serves as the primary quality representative supporting manufacturing operations and product lifecycle management. This position will work closely with AtriCure Engineering, Manufacturing, Regulatory, and Supplier Quality to ensure manufacturing product quality, risk management, continuous improvement, and regulatory compliance of AtriCure products and processes. This individual will have a technical foundation and must be able to lead and coordinate activities related to daily operations. \nESSENTIAL FUNCTIONS OF THE POSITION:\nProvides daily Quality Engineering support of manufacturing operations where daily activities require working with collaborative cross-functional teams. Daily tasks require the timely addressing of product line issues through correction and prevention processes.\nWith respect to direct line responsibility, the QE manages, and coordinates required activities from functions (ie. Engineering, Manufacturing, Supplier Quality, Inspection, Document Control) and processes (ie. NCR, Investigation, FMEAs, Rework, Deviations, CAPA)\nChairs the MRB for respective product line.\nLeads and/or supports risk management activities including risk assessments, pFMEAs, health hazard evaluations, and implementation of risk control measures throughout the product lifecycle.\nAnalyzes quality metrics, manufacturing trends, and process performance indicators to identify risks and drive improvement initiatives with cross-functional peers.\nContributes to new product development and transfer by supporting Design Assurance (and NPD Teams) as required. Examples would include inspection/control plan development and the establishment of compliant production and process controls during production transfer\nLeads and/or supports protocol development, execution, review and approval activities for process validation, equipment qualification, test method validation, and manufacturing line transfers.\nContributes to the development and implementation of quality system processes, including regulatory requirements, as applicable.\nAssists with 3rd party, internal, and external FDA and ISO audits, as necessary\nApplies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with little guidance from management, and resolves problems/conflicts.\nPerforms other duties as assigned\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 required in Engineering or demonstrated equivalent combination of education, training and experience.\n2 - 5 years of experience in a process, manufacturing, or quality engineering role.\nAble to interpret design drawings (including GD&T) and product specifications\nMeasurement System Analysis (Gage R&R) experience a plus\nExperience with process validation, design verification/design validation\nProblem solving/Troubleshooting experience\nUnderstanding of Lean Manufacturing tools such as value stream mapping, 6S, Kaizen, etc. a plus\nStrong interpersonal, organizational, and communication skills.\nFDA and ISO 13485 knowledge\nMetrology, auditing and data analysis experience\nComputer/data entry skills\nWritten/report writing skills\nExperience training production associates, inspectors, or junior engineers.\nExperience with industrial or manufacturing statistics\nPREFERRED QUALIFICATIONS:\nExperience as a quality or manufacturing engineer at a medical device company\nMDD, MDR, CMDR and JPAL knowledge\nRegulatory experience\nExperience with design verification / design validation\nKnowledge of EO and Gamma sterilization processes.\nEngineering/design background\nOTHER REQUIREMENTS:\nAbility to regularly walk, sit, or stand as needed\nAbility to occasionally bend and push/pull as needed\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":6575,"description_truncated":false,"requirements":{"experience_years_min":2,"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","Healthcare & Life Sciences Consulting"],"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":"2026-10-03T21:08:04+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":"2026-10-03T21:09:13+00:00","sources":["UK Home Office: register of licensed sponsors (workers)"],"filings_for_role_12m":0}],"liveness":{"score":15,"band":"cold","label":"Long shot","p_open":1,"p_active":0.533,"p_room":0.28,"age_days":45,"expected_fill_days":21,"reasons":["conf:30","win:tail","crowd:junior"],"computed_at":"2026-10-03T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/atricure-quality-engineer","json_url":"https://alion.io/job/atricure-quality-engineer.json","meta":{"generated_at":"2026-10-04T01:58:46Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":2685,"day_limit":5000,"remaining_today":2315,"minute_limit":60,"resets_at":"2026-10-05T00:00:00Z"}}}