Quality Technician
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.
We 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.
POSITION SUMMARY:
The Primary Quality Technician, RMI is responsible for a variety of activities to support Production, Quality, Engineering and Product Development. This includes using a variety of mechanical and electrical inspection equipment, developing inspection methods and reviewing blueprints and technical specifications. This individual is responsible for all documentation required by the quality system, and ensuring all documentation is complete and accurate.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Ensures all appropriate activities are within compliance to AtriCure’s Quality System, Company policies, FDA regulations and ISO requirements
- Complete First Article Inspections as requested
- Assist in mentoring Quality Inspectors
- Support Suppliers, Engineering, Inspection, and Equipment Calibration with daily activities including inspections, equipment review, documentation updates and complaint investigation.
- Support the development of inspection methods for new product
- Support the improvement of inspection efficiencies through automation and inspection method improvements
- Review blueprints with Product Development and Engineering for accuracy and ability to inspect
- Serve as a backup for the Quality Inspection team in support of incoming, in-process and/or finished goods inspection as needed
- Supporting Rework activities as required by AtriCure’s Quality Systems procedures
- Demonstrate problem solving skills for root cause investigation, corrective/preventative action, and process/inspection improvement projects
- Support and prioritize projects, adapt to shifting priorities, work with moderate independence, able to resolve problems/conflicts
- Assist with FDA, BSI and ISO audits.
- Other duties as necessary and assigned
BASIC QUALIFICATIONS:
- High School graduate or equivalent.
- Ability to read technical specifications, blueprints, and drawings (ASME Y14.5 & ASME Y14.100)
- 4+ years of advanced knowledge of GD&T (ASME Y14.5 1994 or greater) (Datums, Position, Flatness, Perpendicularity, Parallelism, Profile, Runout, and Material modifiers)
- 4+ years of experience with common inspection/testing equipment and gauges (Ruler/Scale, Tape Measure, Calipers, Micrometers, Pin gauges, Drop/Dial Indicators, Height Gauge, etc.)
- 4+ years of experience with advanced/uncommon inspection/testing equipment and gauges (Sine plate, Thread micrometer, universal micrometers, hardness tester, profilometer, durometer, etc.)
- 4+ years of experience with pneumatic, electrical, and environmental inspection/testing equipment and gauges (Multimeter, pressure gauge, flowmeter, humidity and temperature meters)
- 2+ years of experience programming CNC Vision systems for automation (OGP SmartScope, Keyence, Starrett) (MeasureMind 3D, Zone-3, Keyence IM-8000)
- Strong computer/data entry, report writing, and communication skills (Microsoft Excel, Word & Outlook)
- Problem solving/trouble shooting experience
- Specific vision abilities include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus
- Willing to travel < 10%
PREFERRED QUALIFICATIONS:
- 6+ years advanced knowledge of GD&T (ASME Y14.5 1994 or greater)
- 4+ years of programming CNC Vision System for automation (OGP, Keyence, Starrett) (MeasureMind 3D, Zone-3, Keyence IM-8000)
- 4+ years of programming experience with CMM (PolyWorks with PH10M and Nikon Laser)
- Experience with tensile/strain and other material testing (Instron, BlueHill Universal)
- Experience with SolidWorks
- Experience with 3D printing
- 2+ years of experience in a regulated manufacturing industry (Medical, Automotive, Aerospace)
- ASQ, CQI, or CQT Certification
OTHER REQUIREMENTS:
- Ability to regularly walk, sit, or stand as required
- Ability to occasionally bend and push/pull
- Ability to regularly lift up to 10 pounds, occasionally lift up to 25 pounds.
- Ability to use hands to grasp and manipulate small parts in a repetitive motion
- On Demand overtime to meet production schedule may be required
- Ability to pass pre-employment drug screen and background check
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AtriCure 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, 20 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. AtriCure 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).
Other details
- Job Family Quality Technician
- Job Function Quality
- Pay Type Hourly
- Employment Indicator Non Manager