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AtriCure, Inc. Verified
Medical Devices, Healthcare, Biotechnology

Quality Engineer

Mason, OHOnsiteFull TimePosted 2 months agoVisa sponsorship available

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Required skills

  • product specifications
  • process validation
  • FDA
  • ISO 13485
  • metrology
  • auditing
  • data analysis
  • computer skills
  • data entry
  • written report writing

Nice to have

  • MDD
  • MDR
  • CMDR
  • JPAL
  • regulatory experience
  • EO sterilization

Role summary

The Quality Engineer is responsible for supporting manufacturing operations and product lifecycle management, ensuring product quality, risk management, continuous improvement, and regulatory compliance. This role requires a technical foundation to lead daily operations, address product issues, manage quality processes (NCR, CAPA, FMEA), and chair the MRB. The engineer will also lead risk management activities, analyze quality metrics, contribute to new product development, and support validation protocols. A Bachelor's degree in Engineering and 2-5 years of experience in a relevant role are required, along with the ability to interpret design drawings (GD&T) and understand manufacturing statistics. Experience with process validation, design verification/validation, and problem-solving is essential. Preferred qualifications include experience in the medical device industry and knowledge of specific regulations and sterilization processes.

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 AtriCure.com 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:

The Quality Engineer serves as the primary quality representative supporting manufacturing operations and product lifecycle management. This position will work closely with AtriCure Engineering, Manufacturing, Regulatory, and Supplier Quality to ensure manufacturing product quality, risk management, continuous improvement, and regulatory compliance of AtriCure products and processes. This individual will have a technical foundation and must be able to lead and coordinate activities related to daily operations.

ESSENTIAL FUNCTIONS OF THE POSITION:

  • Provides daily Quality Engineering support of manufacturing operations where daily activities require working with collaborative cross-functional teams. Daily tasks require the timely addressing of product line issues through correction and prevention processes.
  • With respect to direct line responsibility, the QE manages, and coordinates required activities from functions (ie. Engineering, Manufacturing, Supplier Quality, Inspection, Document Control) and processes (ie. NCR, Investigation, FMEAs, Rework, Deviations, CAPA)
  • Chairs the MRB for respective product line.
  • Leads and/or supports risk management activities including risk assessments, pFMEAs, health hazard evaluations, and implementation of risk control measures throughout the product lifecycle.
  • Analyzes quality metrics, manufacturing trends, and process performance indicators to identify risks and drive improvement initiatives with cross-functional peers.
  • Contributes to new product development and transfer by supporting Design Assurance (and NPD Teams) as required. Examples would include inspection/control plan development and the establishment of compliant production and process controls during production transfer
  • Leads and/or supports protocol development, execution, review and approval activities for process validation, equipment qualification, test method validation, and manufacturing line transfers.
  • Contributes to the development and implementation of quality system processes, including regulatory requirements, as applicable.
  • Assists with 3rd party, internal, and external FDA and ISO audits, as necessary
  • Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with little guidance from management, and resolves problems/conflicts.
  • Performs other duties as assigned

    • 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 required in Engineering or demonstrated equivalent combination of education, training and experience.
  • 2 - 5 years of experience in a process, manufacturing, or quality engineering role.
  • Able to interpret design drawings (including GD&T) and product specifications
  • Measurement System Analysis (Gage R&R) experience a plus
  • Experience with process validation, design verification/design validation
  • Problem solving/Troubleshooting experience
  • Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kaizen, etc. a plus
  • Strong interpersonal, organizational, and communication skills.
  • FDA and ISO 13485 knowledge
  • Metrology, auditing and data analysis experience
  • Computer/data entry skills
  • Written/report writing skills
  • Experience training production associates, inspectors, or junior engineers.
  • Experience with industrial or manufacturing statistics

    • PREFERRED QUALIFICATIONS:

  • Experience as a quality or manufacturing engineer at a medical device company
  • MDD, MDR, CMDR and JPAL knowledge
  • Regulatory experience
  • Experience with design verification / design validation
  • Knowledge of EO and Gamma sterilization processes.
  • Engineering/design background

    • 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

    • #LI-KN1

    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, 30 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: https://www.atricure.com/careers-atricure/benefits.

    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. 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).

    You may access our global privacy policy here: https://www.atricure.com/privacy

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