AtriCure, Inc.
Overview
Mason HQ, Mason, Ohio, United States of America
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.
Position Summary POSITION SUMMARY:
The Associate Engineer will contribute to the company’s success through the development and delivery of innovative medical devices. This position reports to Product Development Management in the Ablation Franchise. This position contributes in a collaborative way with management, project teams, production associates, external vendors and other work groups to achieve the company’s goals of producing market-leading products that generate positive patient outcomes.
Responsibilities
Execute development tasks to include design, development, and formal testing of medical devices.
Develop and validate test methods for new product features and functions.
Participate in input / feedback from key customers – surgeons, nurses, and other clinicians.
Establish understanding of clinical procedures and techniques applicable to AtriCure products.
Generate protocols and plans for verification and validation studies, and provide direct support in the studies.
Operate and maintain engineering laboratory systems and equipment.
Create and maintain concise technical documentation.
Generate individual work plans, and coordinates activities with product development teams.
Contribute to the generation and documentation of intellectual property.
Perform a variety of engineering design and development tasks, to include design, analysis, prototyping, first-article inspections, in-vivo and in-vitro testing, and user validation.
May mentor engineering students / co-ops.
Additional Responsibilities
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 (mechanical or biomedical preferred).
Knowledge of Design Controls and FDA QSR 21 Part 820 and ISO13485
Demonstrated understanding of protocol/report writing.
Must have proficiency in planning work in support of cross-functional team environment.
Requires engineering aptitude and active participation in the technical advancement of the programs.
Able to evaluate scientific options, establish work schedules and estimate resource requirements.
Skilled in written and oral communication.
Trained in data analysis, problem-solving, troubleshooting and formal root-cause analysis techniques.
Capable of prioritizing tasks and provide a timely schedule of completion.
Ability to travel 20%
Preferred Qualifications
BS degree in a technical field with 2+ years of medical device experience is preferred.
Experience using MS Project to schedule and manage tasks in development projects.
Proven track record of generating and documenting development tasks, protocols, and reports.
Experience in the development of capital equipment as well as single-patient use disposables.
Experience in PMA and 510k device development.
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
For further information about benefits and eligibility, AtriCure participates in the federal E-Verify program and is an Equal Employment Opportunity/Affirmative Action employer. 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 or any other characteristic protected by law.
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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.
Position Summary POSITION SUMMARY:
The Associate Engineer will contribute to the company’s success through the development and delivery of innovative medical devices. This position reports to Product Development Management in the Ablation Franchise. This position contributes in a collaborative way with management, project teams, production associates, external vendors and other work groups to achieve the company’s goals of producing market-leading products that generate positive patient outcomes.
Responsibilities
Execute development tasks to include design, development, and formal testing of medical devices.
Develop and validate test methods for new product features and functions.
Participate in input / feedback from key customers – surgeons, nurses, and other clinicians.
Establish understanding of clinical procedures and techniques applicable to AtriCure products.
Generate protocols and plans for verification and validation studies, and provide direct support in the studies.
Operate and maintain engineering laboratory systems and equipment.
Create and maintain concise technical documentation.
Generate individual work plans, and coordinates activities with product development teams.
Contribute to the generation and documentation of intellectual property.
Perform a variety of engineering design and development tasks, to include design, analysis, prototyping, first-article inspections, in-vivo and in-vitro testing, and user validation.
May mentor engineering students / co-ops.
Additional Responsibilities
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 (mechanical or biomedical preferred).
Knowledge of Design Controls and FDA QSR 21 Part 820 and ISO13485
Demonstrated understanding of protocol/report writing.
Must have proficiency in planning work in support of cross-functional team environment.
Requires engineering aptitude and active participation in the technical advancement of the programs.
Able to evaluate scientific options, establish work schedules and estimate resource requirements.
Skilled in written and oral communication.
Trained in data analysis, problem-solving, troubleshooting and formal root-cause analysis techniques.
Capable of prioritizing tasks and provide a timely schedule of completion.
Ability to travel 20%
Preferred Qualifications
BS degree in a technical field with 2+ years of medical device experience is preferred.
Experience using MS Project to schedule and manage tasks in development projects.
Proven track record of generating and documenting development tasks, protocols, and reports.
Experience in the development of capital equipment as well as single-patient use disposables.
Experience in PMA and 510k device development.
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
For further information about benefits and eligibility, AtriCure participates in the federal E-Verify program and is an Equal Employment Opportunity/Affirmative Action employer. 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 or any other characteristic protected by law.
#J-18808-Ljbffr