Associate Design Assurance Quality Engineer

1 week ago

Cincinnati, United States AtriCure Full time

Associate Design Assurance Quality Engineer

Cincinnati, OH, USA ● Dayton, OH, USA ● Mason, OH, USA Req #2206 Monday, September 9, 2024

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 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:

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.

ESSENTIAL FUNCTIONS OF THE POSITION:

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

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 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. Ability to travel 10%

PREFERRED QUALIFICATIONS:  

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

OTHER REQUIREMENTS:

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

#LI-RD1

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, 20 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: 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  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).

Other details

Job Family Design Assurance Pay Type Salary Employment Indicator Non Manager Share this job:

  • Quality Assurance Engineer

    2 weeks ago

    Cincinnati, Ohio, United States AtriCure Full time

    About the RoleAtriCure is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality of our products and processes.Key ResponsibilitiesProvide daily Quality Engineering support of manufacturing operations, working closely with cross-functional teams to address...

  • Associate, Quality Assurance

    1 month ago

    Cincinnati, Ohio, United States Danaher Corporation Full time

    Mammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, you're collaborating with a global team of engineers, designers, communicators, strategists, and specialists to improve patient outcomes. If you want to be inspired to grow every day, join our...

  • Quality Assurance Engineer

    2 weeks ago

    Cincinnati, Ohio, United States Specialized Recruiting Group Full time

    Job OverviewSpecialized Recruiting Group is in search of a Quality Assurance Engineer to fulfill 1st Shift Direct Hire roles.Key Responsibilities:Supervise the setup and functionality of various mechanical systems.Diagnose and rectify machine and equipment issues.Conduct regular preventative maintenance.Create and deliver schematic design proposals.Identify...

  • Software Quality Assurance Engineer

    2 months ago

    Cincinnati, United States Western & Southern Financial Group Full time

    Summary of Responsibilities:Applies technical skill sets and knowledge to develop and employ complete and accurate test plans for implementation of new products and/or system enhancements. Responsible for functional and interface testing deliverables of Enterprise systems. Works with minimal supervision and is responsible for making established range of...

  • Software Quality Assurance Engineer

    2 months ago

    Cincinnati, United States Western & Southern Financial Group Full time

    Summary of Responsibilities:Applies technical skill sets and knowledge to develop and employ complete and accurate test plans for implementation of new products and/or system enhancements. Responsible for functional and interface testing deliverables of Enterprise systems. Works with minimal supervision and is responsible for making established range of...

  • Quality Assurance Engineer

    2 weeks ago

    Cincinnati, Ohio, United States Pexco Plastic Extrusion Full time

    Job OverviewThe Quality Assurance Engineer plays a pivotal role in enhancing operational excellence within a Custom Injection Molding setting. This role encompasses a wide range of quality engineering and measurement support for the production of goods and processes, while also spearheading system improvements and managing projects across various...

  • Senior Quality Assurance Engineer

    1 week ago

    Cincinnati, Ohio, United States L3Harris Technologies Full time

    Job Title: Senior Quality Assurance EngineerJob Description: L3Harris Technologies is a leading provider of advanced systems and solutions in the defense and aerospace sectors. We are seeking a dedicated Senior Quality Assurance Engineer to join our team, focusing on the assurance of product quality and compliance with contractual obligations. This role is...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Cincinnati, Ohio, United States Cps4jobs Full time

    We are seeking a Lead Quality Assurance Engineer to join our dynamic team at Cps4jobs. This role is pivotal in enhancing our operational excellence and ensuring compliance with industry standards. Key Responsibilities: Oversee and manage complex quality assurance projects, ensuring alignment with corporate objectives. Identify critical areas for improvement...

  • Quality Assurance Engineer in Manufacturing

    2 weeks ago

    Cincinnati, Ohio, United States GENERAL TOOL COMPANY Full time

    *Candidates must be local or willing to relocate to Cincinnati, OH (Onsite position)*This is a full-time/direct-hire position, not a contractFUNCTION:The Quality Assurance Engineer will oversee all quality management and control activities related to specific customer hardware at GTC. This role involves collaboration with GTC associates across various...

  • Quality Assurance Engineer

    2 weeks ago

    Cincinnati, Ohio, United States Ascendum Solutions Full time

    12 month contract to hire, full benefits/PTO provided prior to full-time conversion.Position OverviewWe are seeking a dedicated Quality Assurance Engineer to support our quality assurance programs and processes in alignment with our QA strategy and deliverables within an Agile/Scrum framework. This role requires minimal guidance and is pivotal in ensuring...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Cincinnati, Ohio, United States Northrop Grumman Full time

    Join Northrop Grumman as a Lead Quality Assurance EngineerAt Northrop Grumman, we offer our employees remarkable opportunities to engage in groundbreaking systems that influence lives globally, both now and in the future.Our innovative and creative ethos has positioned us at the forefront of numerous technological milestones in our nation's journey - from...

  • Mobile Quality Assurance Engineer

    2 weeks ago

    Cincinnati, Ohio, United States Flexton Inc. Full time

    Job Title: Mobile Quality Assurance EngineerLocation: Remote/Hybrid RoleDuration: Long-term ContractJob OverviewThe Mobile Quality Assurance Engineer will play a crucial role in ensuring the quality of our Android applications. This position involves reviewing project artifacts developed during the requirements and analysis phases, crafting comprehensive...

  • Quality Assurance Engineer

    1 week ago

    Cincinnati, Ohio, United States Ascendum Solutions Full time

    12 month contract to hire, full benefits/PTO provided prior to full-time conversion.Position OverviewWe are seeking a dedicated Quality Assurance Engineer to enhance our quality assurance programs and processes in accordance with our QA strategy and deliverables within an Agile/Scrum framework. This role involves providing constructive feedback on artifacts...

  • Quality Assurance Specialist

    2 weeks ago

    Cincinnati, Ohio, United States General Tool CO Full time

    FUNCTION: Oversee all quality assurance and control activities for designated General Tool Co. customer hardware, collaborating with General Tool Co. associates across various departments, as well as customer and regulatory inspectors. A primary focus of these responsibilities is the prompt and long-term resolution of product nonconformities identified both...

  • Supplier Quality Assurance Engineer

    2 weeks ago

    Cincinnati, Ohio, United States GE Renewable Energy Power and Aviation Full time

    Job OverviewThe Supplier Quality Assurance Engineer will play a pivotal role in supporting the Supply Chain at GE Renewable Energy Power and Aviation. This position focuses on ensuring quality standards for designated suppliers, including the execution of quality plans. Responsibilities include conducting First Article Inspections, addressing non-conformance...

  • Aerospace Quality Assurance Engineer

    2 weeks ago

    Cincinnati, Ohio, United States Centennial Full time

    Join Our Team as a Quality Assurance Engineer in AerospaceAre you a detail-oriented quality assurance expert committed to excellence in production?We are excited to partner with a leading manufacturing firm specializing in Aerospace and Defense, seeking a Quality Assurance Engineer. This organization is a key player in delivering robust solutions for vital...

  • Quality Assurance Manager

    1 month ago

    Cincinnati, United States Robot Solutions Full time

    Job DescriptionJob Description Job Type: Full TimeSalary: DOEBenefits: 401k AvailableStart Date: Immediate Robot Solutions is a small manufacturing company, located in Cincinnati, Ohio, that manufactures and assembles components for the aerospace and military industries. The company is currently seeking a Quality Assurance Manager/Inspector to set up a...

  • Quality Assurance Manager

    5 days ago

    Cincinnati, United States Gateway Recruiting, INC. Full time

    Job DescriptionJob DescriptionSUMMARY:The Manager of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR).  This position reports to the US CEO and indirectly to the Group Director of Quality Management and Regulatory Affairs.This role encompasses a...

  • Quality Assurance Engineer

    3 days ago

    Cincinnati, United States Certec, Inc. Full time

    Quality Assurance Engineer12+ Months Contract (W2) [Strictly No Third Party Candidates]Location: Remote (Onsite required for the 1st day in Ohio)Job Overview: We are seeking a highly skilled and experienced Quality Assurance (QA) Analyst with strong analytical and conceptual thinking abilities. This role demands expertise in test automation and QA...

  • Quality Assurance Engineer

    2 days ago

    Cincinnati, United States Certec, Inc. Full time

    Quality Assurance Engineer12+ Months Contract (W2) [Strictly No Third Party Candidates]Location: Remote (Onsite required for the 1st day in Ohio)Job Overview: We are seeking a highly skilled and experienced Quality Assurance (QA) Analyst with strong analytical and conceptual thinking abilities. This role demands expertise in test automation and QA...