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Senior Metrology Engineer

AtriCure

AtriCure

Mason, OH, USA
Posted on Thursday, August 24, 2023

Senior Quality Engineer - Calibrations

Mason HQ, 7555 Innovation Way, Mason, Ohio, United States of America Req #1644
Tuesday, September 19, 2023
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:


This individual fulfilling this role will have a metrology foundation and shall be able to lead and coordinate calibration activities related to daily and future operations. This position will work closely with AtriCure engineering, manufacturing, supplier quality, to ensure that quality system activities are completed.



ESSENTIAL FUNCTIONS OF THE POSITION:



  • Provides daily Quality Engineering calibration direction for inspection and testing operations where daily activities require working with collaborative cross-functional teams. Daily tasks require the timely addressing of calibration-based issues through correction and prevention processes. Specific responsibilities:

  • Responsible for the development and release of operational procedures & forms for the calibration program of current and future state of calibrations at ATRC.

    • Development is done through collaboration with manager, calibration technicians, and stakeholders. Typical program development would include documented gap analysis, development of overall plan, and implementation of the program.



  • Current activities include:

    • Owning and completing timely processing of all calibration program-based NCRs, INVs, and CAPAs.

    • Routinely using data, risk analysis, cost/benefit decision-making to adjust calibration intervals.

    • Assisting Calibration Technicians in developing processes for tracking device location and usage before devices are to be calibrated.

    • Leading the GR&R studies (protocols and reports) for Receiving Materials Inspection in accordance with TMV procedures.

    • Assisting in the measurement alignment of RMI and Supplier inspection methods as it relates to GR&Rs and Calibration.

    • Acting as consultant to other functions performing GR&R or TMVs in Production and/or Product Development

    • Leading in-house calibration initiative through cross functional project management and develops in house program and procedures.



  • Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with little guidance from management, and resolves problems/conflicts.

  • Contributes to the development and implementation of quality system processes, including regulatory requirements, as applicable.

  • Assists with 3rd party, internal, and external FDA and ISO audits, as necessary.

  • Performs other duties as assigned.



ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:



  • Regular and predictable work performance

  • Ability to work under fast-paced conditions.

  • Ability to make decisions and use good judgment.

  • Ability to prioritize various duties and multitask as required.

  • Ability to successfully work with others.



  • Additional duties as assigned.



BASIC QUALIFICATIONS:



  • Bachelor’s degree required in Engineering or demonstrated equivalent combination of education, training and experience.

  • 5 - 7 years of experience in a process, manufacturing, or quality engineering role.

  • 2+ years’ experience with Calibration/Metrology programs including performing GR&Rs, ensuring NIST traceability, and performing data analysis.

  • Working knowledge of ISO17025

  • Able to interpret design drawings (including GD&T) and product specifications.

  • Problem solving/Troubleshooting experience.

  • Strong interpersonal, organizational, and communication skills.

  • Computer/data entry and protocol/report writing skills.

  • Experience training production associates, inspectors, or junior engineers.



PREFERRED QUALIFICATIONS:



  • FDA, 13485, MDD, MDR, CMDR and JPAL knowledge

  • Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kazan, etc. a plus

  • Engineering/design background

  • Experience with process validation, design verification/design validation



OTHER REQUIREMENTS:



  • Ability to regularly walk, sit, or stand as needed.

  • Ability to occasionally bend and push/pull as needed.

  • Ability to pass pre-employment drug screen and background check.

  • Ability to travel to calibration sources as needed.


#LI-KN1
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/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 Engineering
  • Job Function Quality
  • Pay Type Salary
  • Employment Indicator Non Manager
Other details