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Staff Manufacturing Engineer
Staff Manufacturing EngineerAtriCure, • Mason, OH, US
Staff Manufacturing Engineer

Staff Manufacturing Engineer

AtriCure, • Mason, OH, US
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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.

Staff Manufacturing Engineer

AtriCure, Inc. has an opening for the Staff Manufacturing Engineer in Mason, OH who is responsible for developing, validating, and maintaining capable and stable manufacturing processes to meet product quality standards / requirements.

Duties include :

  • Ensure continuous improvement in process, cost, quality, and production;
  • Mentor members of the Manufacturing / Process Engineering Teams;
  • Support and drive a continuous improvement culture within the PD teams and the operations organization;
  • Define high level manufacturing system / flow requirements and select appropriate manufacturing processes to achieve required tolerances, production capacities, and cost targets;
  • Collaborate with product design engineers to identify and implement Design for Manufacture / Design for Assembly improvements;
  • Apply lean manufacturing (Toyota production system) principles to the design of manufacturing processes, facilities layouts, and business processes associated with manufacturing;
  • Participate in development of product requirements and lead manufacturing risk management activities (Process FMEA, Validation Master Plan, Inspection and Test methods);
  • Select suppliers for parts and equipment;
  • Coordinate prototype and pre-production builds;
  • Specify, design, and manage procurement of equipment, fixtures, and tooling; and
  • Apply project management best practices to manufacturing engineering projects including development of work breakdown structures, identification of required resources, budgeting and management of required expenses, and daily task and resource management to achieve expected project outcomes.
  • Anticipated 10% domestic and 5% international travel to AtriCure and supplier sites.

Required :

  • Bachelor's degree in Industrial Engineering, Mechanical Engineering, Production Engineering, Biomedical Engineering, or related field (foreign equivalent degree accepted) with 10 years of progressive, post degree experience as a Manufacturing Engineer, Process Engineer, or a closely related role OR a Master's degree in Industrial Engineering, Mechanical Engineering, Production Engineering, Biomedical Engineering, or related field (foreign equivalent degree accepted) with 8 years of experience as a Manufacturing Engineer, Process Engineer, or a closely related role
  • 8 years of experience in manufacturing process development
  • 5 years of experience in each of the following :
  • Design for Manufacturing (DFM) & Design for Assembly (DFA); and

  • Technical data analysis, application of advanced statistical tools / techniques for the process development and validation activities.
  • 3 years of experience in each of the following :
  • In good manufacturing practices (GMPs) and Good documentation practices (GDPs) in technical writing;

  • Working for a class II or class III medical device manufacturer;
  • In process characterization / design of experiments;
  • Developing manufacturing and project plans and leading projects independently;
  • In fixturing and gages development;
  • In defining high level manufacturing system and flow requirements to design a process;
  • In selecting appropriate manufacturing processes to achieve required tolerances, production capacities, and cost targets; and
  • Applying Geometric Dimensioning & Tolerancing (GD&T).
  • 2 years of experience in manufacturing execution system (MES)
  • Experience may be gained concurrently. Ability to pass pre-employment drug screen and background check is required.

    LI-DNI

    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).

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    Manufacturing Engineer • Mason, OH, US

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