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:
The Quality Engineer serves as the primary quality representative supporting manufacturing operations and product lifecycle management. This position will work closely with AtriCure Engineering, Manufacturing, Regulatory, and Supplier Quality to ensure manufacturing product quality, risk management, continuous improvement, and regulatory compliance of AtriCure products and processes. This individual will have a technical foundation and must be able to lead and coordinate activities related to daily operations.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Provides daily Quality Engineering support of manufacturing operations where daily activities require working with collaborative cross-functional teams. Daily tasks require the timely addressing of product line issues through correction and prevention processes.
- With respect to direct line responsibility, the QE manages, and coordinates required activities from functions (ie. Engineering, Manufacturing, Supplier Quality, Inspection, Document Control) and processes (ie. NCR, Investigation, FMEAs, Rework, Deviations, CAPA)
- Chairs the MRB for respective product line.
- Leads and/or supports risk management activities including risk assessments, pFMEAs, health hazard evaluations, and implementation of risk control measures throughout the product lifecycle.
- Analyzes quality metrics, manufacturing trends, and process performance indicators to identify risks and drive improvement initiatives with cross-functional peers.
- Contributes to new product development and transfer by supporting Design Assurance (and NPD Teams) as required. Examples would include inspection/control plan development and the establishment of compliant production and process controls during production transfer
- Leads and/or supports protocol development, execution, review and approval activities for process validation, equipment qualification, test method validation, and manufacturing line transfers.
- Contributes to the development and implementation of quality system processes, including regulatory requirements, as applicable.
- Assists with 3rd party, internal, and external FDA and ISO audits, as necessary
- Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with little guidance from management, and resolves problems/conflicts.
- Performs other duties as assigned
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- 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 required in Engineering or demonstrated equivalent combination of education, training and experience.
- 2 - 5 years of experience in a process, manufacturing, or quality engineering role.
- Able to interpret design drawings (including GD&T) and product specifications
- Measurement System Analysis (Gage R&R) experience a plus
- Experience with process validation, design verification/design validation
- Problem solving/Troubleshooting experience
- Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kaizen, etc. a plus
- Strong interpersonal, organizational, and communication skills.
- FDA and ISO 13485 knowledge
- Metrology, auditing and data analysis experience
- Computer/data entry skills
- Written/report writing skills
- Experience training production associates, inspectors, or junior engineers.
- Experience with industrial or manufacturing statistics
PREFERRED QUALIFICATIONS:
- Experience as a quality or manufacturing engineer at a medical device company
- MDD, MDR, CMDR and JPAL knowledge
- Regulatory experience
- Experience with design verification / design validation
- Knowledge of EO and Gamma sterilization processes.
- Engineering/design background
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
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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, 30 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).
You may access our global privacy policy here: https://www.atricure.com/privacy
Skills Required
- Bachelor's degree in Engineering or equivalent education, training, and experience
- 2–5 years of experience in process, manufacturing, or quality engineering
- Ability to interpret design drawings, including GD&T, and product specifications
- Experience with process validation and design verification/design validation
- Problem-solving and troubleshooting experience
- Strong interpersonal, organizational, and communication skills
- Knowledge of FDA requirements and ISO 13485
- Metrology, auditing, and data analysis experience
- Computer and data-entry skills
- Written communication and report-writing skills
- Experience training production associates, inspectors, or junior engineers
- Experience with industrial or manufacturing statistics
- Measurement System Analysis or Gage R&R experience
- Knowledge of Lean Manufacturing tools, including value stream mapping, 6S, and Kaizen
- Experience as a quality or manufacturing engineer at a medical device company
- Knowledge of MDD, MDR, CMDR, and JPAL
- Regulatory experience
- Knowledge of EO and Gamma sterilization processes
- Engineering or design background
What We Do
AtriCure provides innovative atrial fibrillation (Afib) solutions designed to produce outcomes that reduce the economic and social burden of Afib.
