Staff Design Assurance Quality Engineer

AtriCure•Mason, OH

About The Position

POSITION SUMMARY: This position will be part of one or more product development teams where they will be responsible for contributing to the on-time development of high-quality products. This position will also be responsible for supporting and leading activities related to trending quality field performance. This position will be responsible for subsequent improvements for marketed products and optimization of design control processes as needed. ESSENTIAL FUNCTIONS OF THE POSITION: On time quality delivery of assigned product development team deliverables Ensure assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations. 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 Develop new processes which support speed, cost reductions and quality improvements Provide subject matter expertise for assigned processes to users as necessary. Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions Provide coaching respective to investigative methods, risk mitigation techniques, DOE, statistical analysis, Reliability, and other related techniques (including Six Sigma, FTA, FMEA, HALT, etc.) Provide guidance for development of manufacturing test/evaluation methods and process validationProvides investigative support/leadership for product quality issuesWork with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controlsWork with product development teams on timely use of Risk Management activities including supporting and leading FMEAs and essential requirements analysis including standards review and evidence of conformity.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 developmentEnsure commitment to functional excellence and the ability to execute positive changes 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 Ability to mentor and coach others Additional duties as assigned

Requirements

Bachelor’s degree in Engineering required or demonstrated equivalent combination of education, training and experience.
Minimum of 7 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
Ability to travel 10%

Nice To Haves

10 years or more 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
Ensure assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations.
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
Develop new processes which support speed, cost reductions and quality improvements
Provide subject matter expertise for assigned processes to users as necessary.
Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions
Provide coaching respective to investigative methods, risk mitigation techniques, DOE, statistical analysis, Reliability, and other related techniques (including Six Sigma, FTA, FMEA, HALT, etc.)
Provide guidance for development of manufacturing test/evaluation methods and process validationProvides investigative support/leadership for product quality issues
Work with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls
Work with product development teams on timely use of Risk Management activities including supporting and leading FMEAs and essential requirements analysis including standards review and evidence of conformity.
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