Principal Quality Operations Engineer

AtriCure; Mason (OH); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Medical & Dental

401K matching

Parental Leave

Job summary

AtriCure, Inc. is seeking a Principal Quality Operations Engineer to provide enterprise leadership over manufacturing infrastructure, critical facility systems, and utility systems.

You will define quality strategy, governance, and lifecycle expectations, including risk assessment, validation, change control, and continuous improvement to ensure compliance and inspection readiness. The role requires leading cross-functional teams, developing Quality Plans and validation master plans, and

Qualifications

• Bachelor’s degree in engineering or equivalent.
• Minimum 10 years of experience in Medical Device Manufacturing or regulated industry.
• Experience with facility, utility, equipment validation in a regulated manufacturing environment.
• Working knowledge of ISO 13485, GMP, quality system procedures, and validation standards.

Responsibilities

• Lead risk management for critical facility and utility systems.
• Define quality documentation expectations for facility systems and related records.
• Establish validation plans and lifecycle management for major facility updates.
• Provide technical authority for IQ/OQ/PQ documentation and lifecycle activities.
• Mentor Quality Operations engineers and guide cross-functional teams.

Skills

Risk management

Quality systems

Project leadership

Communication

Education

Bachelor’s degree in engineering

Tools

MS Office

Data analysis tools

Job description

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 Principal Quality Operations Engineer provides enterprise technical leadership and quality oversight for the manufacturing infrastructure, critical facility systems, and utility systems that support compliant, reliable production. This position is accountable for defining the quality strategy, governance, and lifecycle expectations for these systems, including risk assessment, system and process validation, change control, program management, and continuous improvement. This includes ownership of the policies, procedures, controls, and quality practices that govern these systems. The role serves as a senior technical authority and trusted advisor, influencing cross-functional decisions to ensure facility and utility systems remain capable, controlled, inspection-ready, and aligned with applicable regulatory requirements and the AtriCure Quality Management System.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Lead the risk management program for critical facility and utility systems, including risk governance, escalation, timely investigation, and implementation of mitigations for identified risks, excursions, and quality issues.
• Define quality documentation expectations for facility and utility systems, including user needs, requirements, drawings, specifications, risk documentation, validation evidence, process controls, and related records.
• Establish quality strategies, Quality Plans, and validation master plans to guide large facility updates, utility changes, and critical system lifecycle management in alignment with AtriCure validation and quality system policies.
• Lead strategic quality and facility implementation programs from initiation through completion, including priorities, deliverables, resource alignment, stakeholder engagement, risk-based decision-making, and executive-level status communication.
• Advise cross-functional teams on facility change requests, including line moves, equipment moves, utility additions, and related changes that support production operations and require quality impact assessment.
• Provide technical authority for qualification and validation strategies applied to critical facility, utility, equipment, monitoring, and data systems, including development, execution, review, and approval of IQ/OQ/PQ documentation and lifecycle activities.
• Lead validation and data integrity practices for systems that capture critical facility and utility data, including dashboards, alert and action limits, trend monitoring, and escalation of conditions requiring investigation or corrective action.
• Drive development and improvement of quality system procedures and program controls governing critical facility and utility systems and supporting Quality Operations programs.
• Champion continuous improvement opportunities that increase efficiency, capacity, reliability, compliance, and operational readiness of critical facility and utility systems.
• Serve as a senior quality and engineering resource for facilities management, equipment qualification, process validation, preventive maintenance, and calibration activities related to Quality Operations-owned equipment.
• Influence Facilities, Quality Management, Operations, and other departments to assess system capacity, support company strategies, resolve complex issues, and maintain alignment with business and quality objectives.
• Define and communicate metrics that assess the health, performance, capacity, and compliance status of critical facility and utility systems, including status updates to quality, operational, and leadership forums.
• Represent Quality Operations during internal and external audits, including preparation, response, and follow-up activities related to critical facility and utility systems.
• Mentor Quality Operations engineers, build technical capability across the team, and provide trusted partnership and guidance to key stakeholders.
• Lead with expert knowledge of prescribed GMP, ISO, and GLP standards and ensure compliance with applicable domestic and international regulations, standards, and controls relevant to risk management, process validation, environmental monitoring, and related areas.

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 in engineering, or an equivalent combination of education, training, and experience.
• Minimum of 10 years of experience in the Medical Device Manufacturing Experience, or Manufacturing production and process control experience within a regulated industry.
• Experience with facility, utility, equipment, and/or process validation in a regulated manufacturing environment, preferably medical device manufacturing.
• Working knowledge of production and process controls, ISO 13485, GMP requirements, quality system procedures, and applicable validation standards and practices.
• Ability to develop and implement quality system programs, policies, procedures, technical documentation, validation master plans, and related controls.
• Demonstrated ability to lead cross-functional teams, influence alignment, facilitate decisions, and resolve complex technical and quality issues.
• Strong verbal, written, and presentation skills, including technical protocol and report development, stakeholder communication, and project status reporting.
• Ability to read and interpret technical specifications, blueprints, drawings, and related facility or engineering documentation.
• Strong problem-solving, troubleshooting, attention to detail, compliance orientation, and results-driven execution.
• Proficiency with computer-based systems, data entry, and basic data analysis or statistical tools.
• Ability to travel up to 15%.

PREFERRED QUALIFICATIONS:

• Experience in medical device manufacturing, quality operations, or quality management, preferably supporting sterile medical devices.
• Knowledge of cleanroom validation, contamination control, environmental monitoring, pest control, and facility-related safety practices.
• Facility engineering, facility design, construction, or manufacturing infrastructure experience in a regulated environment.
• Technical file or CAD drawing management experience.
• FDA, ISO, or other regulatory audit experience.
• ASQ Certified Quality Engineer and/or ASQ Certified Six Sigma Black Belt certification.

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
• Ability to pass pre-employment drug screen and background check

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).

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in AtriCure’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

By checking this box, I agree to allow AtriCure to retain my data for future opportunities for employment for up to 730 days after the conclusion of consideration of my current application for employment.

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