Associate Design Assurance Quality Engineer

AtriCure • Mason, OH

6d

About The Position

This position will be part of one or more product development teams where they will be responsible for contributing to the on-time development and sustaining of high-quality products and optimization of core design control business processes. The role involves ensuring assigned design control procedures are compliant with FDA, GMP, ISO, and other applicable standards and regulations. It also focuses on optimizing existing processes for efficiency, driving continuous improvements through observation, measurement, and root cause analysis, and developing new processes that support speed, cost reductions, and quality improvements. The Associate Design Assurance Quality Engineer will collaborate cross-functionally with manufacturing operations, marketing, sales, regulatory, and clinical functions, provide guidance for manufacturing test/evaluation methods and process validation, and offer investigative support for product quality issues. They will work with product development teams to cascade requirements, assure proposed changes meet requirements, and support Risk Management activities including FMEAs and essential requirements analysis. The role requires a commitment to functional excellence and the ability to execute positive changes. Additional functions include regular and predictable work performance, ability to work under fast-paced conditions, make decisions, prioritize duties, multitask, and work successfully with others. Additional duties as assigned.

Requirements

• Bachelor’s degree in Engineering from an accredited college or university or demonstrated equivalent combination of education, training and experience
• 1-3 years of professional experience in a regulated manufacturing industry. Co-op and internship experience is considered relevant experience for this role.
• Experience with quality system process development
• Working knowledge of statistical analysis techniques
• Experience in test method strategies used for design verification and validation
• Experience with risk management methodology
• 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.

Nice To Haves

• At least 1 year experience in an engineering role in Medical Devices
• At least 1 year experience working with Product Development
• Experience in processes related to Design Change Control, Design Reviews, Requirements Management
• Experience with medical device electrical and software standards, testing and marking
• Working knowledge of Reliability assessment techniques
• Experience developing test method strategies, including GR&R

Responsibilities

• On time quality delivery of assigned product development team deliverables, under the guidance of a more senior Design Assurance team member
• 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
• Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions
• Provide guidance for development of manufacturing test/evaluation methods and process validation
• Provides investigative support for product quality issues
• Work with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls, and with sustaining teams to assure proposed changes still meet those requirements
• Work with product development teams on timely use of Risk Management activities including supporting 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
• Ensure commitment to functional excellence and the ability to execute positive changes

Benefits

• Ability to travel 10%
• 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
• Ability to regularly lift up to 25 pounds

What This Job Offers

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