AtriCure
Principal Design Assurance Quality Engineer
Mason, OH · Principal · Contract
Sponsorship not specifiedDetected 29 days ago
StatisticsProcess ImprovementGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationMentoring
About the role
- Ensure product compliance to 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007/2019, MDD 93/42/EEC and EU MDR 22017/745 and 746.
- Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions
- These include risk management plans, hazard analysis, Application or Use FMEAs via failure mode effects analysis, risk mitigations and effectiveness checks, and Risk Management Reports using principles from ISO 14971.
Responsibilities
- On time quality delivery of assigned product development team deliverables by adherence to internal QMS and design controls procedures in compliance with FDA, GMP, ISO and other applicable standards and regulations.
- Responsible to generate and independently maintain project risk management files for new product development projects.
- Provide expertise in development and implementation of C/R strategy, statistical support, inspection, sampling plans, test methods during Design Verification and Design Validation planning using a risk-based approach.
- Participates or leads Technical Design Phase Reviews
- Own applicable corporate quality policies and drive updates based on new standards or regulations for compliance, and/or process improvements for efficient use of QMS.
- Drive continuous improvements through observation, measurement, and root cause analysis/resolution
- Provides investigative support/leadership for product quality issues
- Provide mentorship to junior level design assurance engineers in design control and product development
Requirements
- Experience with business process development
- High level of experience in test method strategies, development and validation including GR&R
- High level of experience with risk management methodology
- Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
- Ability to demonstrate proficiency in issue resolution.
- Ability to multi-task and work with little direction
Nice to have
- 7 or more years' experience working with Product Development
- 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
- 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.
Skills
- AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions.
- Afib affects more than 33 million people worldwide.
- 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.
- For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
Benefits
- https://www.atricure.com/careers-atricure/benefits.
- This position will apply biomedical engineering principles to execute the design controls for medical devices as a part of one or more new product development projects.
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This listing is sourced directly from AtriCure's careers page and normalized into a canonical job model.