Principal Design Assurance Quality Engineer

AtriCure • Mason, OH

2d • Onsite

About The Position

This position will apply biomedical engineering principles to execute the design controls for medical devices as part of one or more new product development projects. 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. This position collaborates with cross-functional teams including Product Development, Manufacturing Operations, Regulatory, Clinical and Marketing to maintain adherence to AtriCure’s QMS planning, execution and implementation activities for New Product Development. Lead the development and enforcement of AtriCure’s risk management activities to ensure patient and user safety through identification of risk-driven product requirements, generation of risk management report/benefit analyses, and participation in post-market product surveillance.

Requirements

• Bachelor’s degree in Engineering required or demonstrated equivalent combination of education, training and experience.
• Minimum of 12 years of experience in an engineering role in the medical device industry
• Experience with business process development
• High level of knowledge in statistical analysis techniques
• 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 create and manage key internal and external partnerships
• Excellent written and verbal communication skills
• High level of attention to detail
• Familiar with product safety and standards
• Ability to demonstrate proficiency in issue resolution.
• Ability to multi-task and work with little direction
• Ability to manage multiple priorities
• Familiar with product safety standards

Nice To Haves

• More than 12 years of experience in an engineering role in Medical Devices
• 7 or more years’ experience working with Product Development
• Experience in processes related to Design Change Control, Design Reviews, Requirements Management
• Certification in ASQ, Six Sigma/Design for Six Sigma

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 for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions
• Responsible to generate and independently maintain project risk management files for new product development projects. 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.
• Drive design assurance into product development through support of user needs/VOCs, product design requirements, design specifications, design verification and validation strategies, usability studies, process qualifications, design reviews and transfer.
• Collaborate with Product development teams to define and cascade user needs/VOC to technical system and subsystem level design requirements through manufacturing requirements, develop rationales, establish traceability to detail designs and Design FMEAs
• 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.
• Provide coaching respective to investigative methods, risk mitigation techniques, DOE, statistical analysis, Reliability, and other related techniques (including Six Sigma, FTA, FMEA, HALT, etc.)
• Participates or leads Technical Design Phase Reviews
• Supports Manufacturing Operations with development of Validation Master Plans, Test Method Validations, Process FMEAs, and Process Validations (IQ, OQ and PQs).
• Maintains product DHFs and DMRs.
• Understanding of global standards and regulations including but not limited to FDA and ISO and Labeling, Packaging, Electrical (IEC 60601), Biocompatibility (ISO 10993) and Sterilization (Gamma, EO or other).
• 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.
• Optimize existing processes to maximize efficiencies and continue to identify, plan, and execute continuous improvement activities.
• Drive continuous improvements through observation, measurement, and root cause analysis/resolution
• Provides investigative support/leadership for product quality issues
• Serve as technical resource for problem investigations to guide root cause analysis and corrective action development.
• Provide mentorship to junior level design assurance engineers in design control and product development
• Ensure commitment to functional excellence and the ability to execute positive changes
• 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
• Ability to mentor and coach others
• Additional duties as assigned

Benefits

• 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
• on-site fitness center
• cafeteria

What This Job Offers

• Job Type: Full-time
• Career Level: Principal