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    Senior Design Assurance Quality Engineer - Mason, United States - Penn Foster Inc

    Penn Foster Inc
    Penn Foster Inc Mason, United States

    3 weeks ago

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    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 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 position will be part of one or more product development teams where they will responsible for contributing to the on-time development of high-quality products.

    This position will also be responsible for supporting and leading activities related to trending quality field performance.

    This will position will be responsible for subsequent improvements for marketed products and optimization of design control processes as needed.



    ESSENTIAL FUNCTIONS OF THE POSITION:
    On time quality delivery of assigned product development team deliverables
    Ensure assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations.
    Optimize existing processes to maximize efficiencies and continue to identify, plan and execute continuous improvement activities.
    Drive continuous improvements through observation, measurement and root cause analysis/resolution
    Develop new processes which support speed, cost reductions and quality improvements
    Provide subject matter expertise for assigned processes to users as necessary.
    Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions
    Provide guidance for development of manufacturing test/evaluation methods and process validation
    Provides investigative support/leadership for product quality issues
    Work with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls

    Work with product development teams on timely use of Risk Management activities including supporting and leading FMEAs and essential requirements analysis including standards review and evidence of conformity.

    Serve as technical resource for problem investigations to guide root cause analysis and corrective action development.
    Provide mentorship to junior level design assurance engineers in design control and product development
    Ensure commitment to functional excellence and the ability to execute positive changes
    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 in Engineering required or demonstrated equivalent combination of education, training and experience.
    Minimum of 5 years of experience in an engineering role in the medical device industry
    Experience with business process development
    Working knowledge in statistical analysis techniques including Reliability assessment
    Experience in test method strategies, development and validation including GR&R
    Experience with risk management methodology
    Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
    Ability to create and manage key internal and external partnerships
    Excellent written and verbal communication skills
    High level of attention to detail
    Familiar with product safety and standards
    Ability to demonstrate proficiency in issue resolution.
    Ability to multi-task and work with little direction
    Ability to manage multiple priorities
    Familiar with product safety standards
    Ability to travel 10%

    PREFERRED QUALIFICATIONS:
    7 years or more experience in an engineering role in Medical Devices
    5 or more years' experience working with Product Development
    Experience in processes related to Design Change Control, Design Reviews, Requirements Management
    Certification in ASQ, Six Sigma/Design for Six Sigma

    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
    #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:
    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- 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).
    #J-18808-Ljbffr
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