Process Engineer

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.

AtriCure, Inc. has an opening for the Process Engineer in Mason, OH is responsible for on-going production, validations, and continuous improvement of new and existing manufacturing processes. The role contributes in a creative and collaborative way to achieve the company's goals of producing market leading products through positive patient outcomes. 5% domestic travel and 1% international travel anticipated to AtriCure sites and supplier sites.

Duties include:

• Ownership of product assembly line technical performance.

• Supports production with troubleshooting assembly line issues, resolution of non-conformances, completion of root cause investigations, and CAPA's.

• Collaborates with cross-functional engineering team (quality, product development, regulatory) to address product line issues.

• Communication of manufacturing and process issues to cross functional engineering team and suppliers, both verbally and in written documentation.

• Reviews proposed component tolerances and input to manufacturing capability.

• Understands GD&T and how to properly apply it to yield the desired fits between joining parts.

• Reviews proposed device assembly requirements and identification of Design for Assembly opportunities.

• Apply understanding of assembly and joining techniques including laser welding, ultrasonic welding, adhesive bonding, over-molding, soldering etc.

• Works with outside suppliers to define, document, analyze and qualify their manufacturing processes.

• Identifies new vendors, processes, materials, and technologies that can be used to improve product quality and reduce product cost and implements manufacturing and product-related cost reduction opportunities.

• Applies continuous improvement methods to enhance yield, consistency, performance, capacity, etc. of equipment and processes.

• Understands quality statistical models and metrics (confidence/reliability intervals, DOE, regression/trending, SPC, t-Tests, acceptance plans).

• Works with designers and engineers in the design and development of manufacturing-related equipment and fixtures.

• Defines and tracks project tooling and equipment schedule and cost.

• Develops detailed process qualification strategies.

• Maintains and updates process maps and FMEAs.

• Conducts time studies and analyze cost variances.

• Evaluates components for conformance to design intent via inspection and functional evaluation.

• Conducts process documentation release using tools such as Visio, Excel, Word, Procal and Master Control documentation release systems.

Required:

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related field (foreign equiv. accepted) & 3 years of experience as an Engineer or closely related role.

• 3 years of experience in each of the following:

• GD&T (Geometric Dimensioning and Tolerancing) for component design and assembly;

• Implementing Design for Manufacturability (DFM) strategies to optimize product designs for efficient and cost-effective manufacturing processes;

• With CAD (Computer-Aided Design) software, statistical analysis software (e.g., Minitab, JMP), process simulation software, and data analysis tools;

• Identifying process issues, troubleshooting problems, and implementing appropriate corrective and preventive actions;

• Manufacturing processes, including design of experiments (DOE), process characterization, process capability analysis, statistical process control (SPC), and lean manufacturing principles;

• Process validation and associated verification activities;

• Equipment selection, design, and qualification for manufacturing processes;

• Managing process changes, including change control procedures and impact assessments;

• Implementing process monitoring systems to track key performance indicators (KPIs) and collect process data for analysis;

• In Lean, Six Sigma, or other continuous improvement methodologies;

• Conducting time and motion studies to establish standard operating procedures for employees in use of equipment;

• Providing training on new processes, equipment, and procedures; and

• Use of standard operating procedures to ensure consistency, safety, and adherence to quality standards.

• 1 year of experience collaborating with suppliers for process-related activities, support, and process transfers.

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

Experience may be gained concurrently.

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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 Process Engineering

• Job Function Operations

• Pay Type Salary

• Employment Indicator Non Manager

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