AtriCure

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.

Principal Manufacturing Engineer

AtriCure, Inc. has an opening for the Principal Manufacturing Engineer in Mason, OH.

Duties include:

• Implement lean manufacturing principles to improve efficiency and reduce waste
• Conduct Design for Manufacturability (DFM) and Design for Assembly (DFA) analyses to ensure product designs are optimized for production;
• Develop and maintain process documentation, including work instructions, process flow diagrams, and control plans;
• Coordinate with cross-functional teams, including R&D, Quality, and Supply Chain, to support new product introductions and process improvements;
• Develop detailed project plans, including timelines, resource allocation, and risk management strategies
• Prepare and present project status reports to senior management;
• Manage multiple projects simultaneously, ensuring timely completion within budget;
• Lead continuous improvement initiatives to enhance product quality and manufacturing efficiency;
• Conduct training sessions and workshops to disseminate best practices and new technologies within the team;
• Provide technical guidance and mentorship to junior engineers and technicians;
• Stay current with industry trends and advancements in manufacturing technologies;
• Develop, specify, procure, and validate manufacturing equipment and tooling;
• Characterize the process parameters and output using design of experiments (DOE);
• Develop and implement preventive maintenance programs for critical equipment;
• Troubleshoot and resolve equipment-related issues to minimize downtime;
• Design and develop custom jigs, fixtures, and tooling to improve manufacturing processes;
• Implement automation solutions to enhance production efficiency and consistency;
• Ensure compliance with regulatory standards (e.g., FDA, ISO 13485) and internal quality systems;
• Conduct root cause analysis and implement corrective actions for process-related issues;
• Collaborate with the Quality Assurance team to develop and execute validation protocols;
• Perform Failure Mode and Effects Analysis (FMEA) to identify and mitigate potential risks in manufacturing processes; and
• 10% domestic travel and 5% international travel anticipated to AtriCure sites and supplier sites.

Required:

• Bachelor’s degree inIndustrial Engineering, Mechanical Engineering, Production Engineering or related field (foreign equivalent degree accepted) and 10 years of progressive, post degree experience as a Manufacturing Engineer or closely related role OR Master’s degree inIndustrial Engineering, Mechanical Engineering, Production Engineering or related field (foreign equivalent degree accepted) and 8 years of progressive, post degree experience as a Manufacturing Engineer or closely related role
• 5 years of experience in each of the following:
  • Manufacturing in the medical device industry;
  • Development of semi-automatic, vision systems, or manual assembly equipment for medical device manufacturing;
  • Implementing Design for Manufacturability (DFM) and Design for Assembly (DFA) strategies to optimize component designs for efficient and cost-effective manufacturing processes;
  • Design of experiments (DOE) or process characterization;
  • Application of advanced statistical tools or techniques (such as process capability analysis and statistical process control) for the process development or validation activities;
  • Fixturing and gages development;
  • Developing manufacturing plans or project plans and independently managing time to lead projects;
  • Good manufacturing practices (GMPs) and Good documentation practices (GDPs) in technical writing; and
  • Applying Geometric Dimensioning & Tolerancing (GD&T).
• 3 years of experience in each of the following:
  • Lean manufacturing principles;
  • Technical writing in the medical device industry; and
  • Mentoring junior engineers in process development and validation activities.
• 2 years of experience leading project review presentations to executive management team

Experience may be gained concurrently. Ability to pass pre-employment drug screen and background check is required.

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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).