
location_onWest Main Street, Mason, Warren County, Ohio, 45040, United States
This position serves as a vital link within product development teams, dedicated to the on-time delivery and sustained quality of high-performance products. The role exists to optimize core design control business processes, ensuring that every deliverable meets rigorous regulatory standards while driving continuous improvement. You will operate in a fast-paced environment where your ability to make sound decisions and prioritize duties is essential for success.
In this capacity, you will collaborate cross-functionally with manufacturing operations, marketing, sales, regulatory, and clinical teams. Your work involves cascading requirements from Voice of the Customer (VOC) through to manufacturing controls, ensuring proposed changes remain compliant with production standards. You will act as a technical resource for problem investigations, guiding root cause analysis and corrective action development to resolve product quality issues effectively.
Candidates selected for this role will undergo a standard evaluation process including a review of qualifications, interviews with the hiring team, and a pre-employment background check and drug screen. Successful candidates must be able to demonstrate proficiency in issue resolution and the ability to work effectively within a team.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all employees.
Work model: On-site
West Main Street, Mason, Warren County, Ohio, 45040, United States
Mason, Ohio
Skills: Fda, GMP, Iso, Root Cause Analysis, Fmeas, Risk Management, Statistical Analysis, Design Verification, Design Validation, Reliability Assessment.
Education: Bachelor's degree in Engineering or equivalent combination of education, training and experience.
At least 1 year experience in an engineering role in Medical Devices. At least 1 year experience working with Product Development. Experience in processes related to Design Change Control, Design Reviews, Requirements Management. Experience with medical device electrical and software standards, testing and marking. Working knowledge of Reliability assessment techniques. Experience developing test method strategies, including GR&R.
AtriCure, Inc. is a medical equipment manufacturing company headquartered in Mason, Ohio, specializing in innovative technologies for the treatment of atrial fibrillation (Afib) and related cardiac conditions. The organization develops devices and procedures used by electrophysiologists, cardiothoracic surgeons, and thoracic surgeons globally to manage Afib, reduce complications, and address post-operative pain management. With Afib affecting over 37 million people worldwide, the company's solutions target a significant patient population seeking effective therapeutic options.
Key offerings include the Isolator Synergy Ablation System, the first medical device to receive FDA approval for treating persistent Afib. The AtriClip Left Atrial Appendage Exclusion System products are recognized as the most widely sold LAA management devices globally. Additionally, the Hybrid AF Therapy provides a minimally invasive procedure for patients with long-standing persistent Afib. The company also manufactures cryoICE cryoSPHERE+ and cryoSPHERE MAX probes, which are cleared for temporary ablation of peripheral nerves to block pain during cardiac and thoracic procedures.
AtriCure maintains a global footprint in the medical technology sector, supporting healthcare professionals in delivering advanced care. For further details regarding products and services, the company directs inquiries to AtriCure.com or its social media channels.
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