Quality Engineer

Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Not specified
Contract type:
Full time
Salary description:
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Start Date:
Job Ref:

AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (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 SynergyTM Ablation System is the first and only medical device to receive FDA approval for the treatment of long standing persistent Afib and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on Position Summary:
This is a technical position assuming various years of experience and different job roles. An Engineering degree or equivalent is required. The job performance requires advanced technical abilities as well as an understanding of product design, manufacturing and quality systems. The Quality Engineer, Operations works closely with AtriCure engineering, manufacturing, service, supplier quality, and suppliers to ensure that quality system activities are completed. This individual will have a strong technical foundation and must be able to lead and coordinate activities related to daily operations. This individual will operate regularly with a cross functional team and shall contribute to the creation of a collaborative work environment.
Roles and Responsibilities:

* Provides daily Quality Engineering support of manufacturing operations where daily activities require working with collaborative cross-functional team.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, HHE)
* Chairs the Material Review Board (MRB) for respective product line.
* Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with minimal guidance from management, and resolves problems / conflicts.
* 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
* Partners with the service department to insure alignment and consistency in diagnosis and service of returned capital equipment systems.
* Partners with complaint handling and sustaining engineering teams to identify and implement solutions to field technical problems associated with capital equipment systems.
* 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
* Assists in the further development of quality engineers.
* Performs other duties as assigned
* 3 - 5 years of experience
* Bachelor's degree in engineering or equivalent
* Knowledge/experience with Instrumentation / Devices / Systems and IEC 60601
* Proficient in interpreting design drawings (including GD&T) and product specifications
* Test Method Validation/Gage R&R experience
* Problem Solving/Troubleshooting experience
* Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kazan, etc.
* Strong interpersonal, organizational, and communication skills.
* Verbal communication and people skills
* FDA and ISO 13485 knowledge
* Auditing experience
* Data analysis experience
* Computer/data entry skills
* Written/report writing skills
* Experience with industrial or manufacturing statistics PREFERRED QUALIFICATIONS:

* Bachelor's or Master's degree in Electrical Engineering
* Experience with medical electrical instrumentation equipment development, support, or technical services
* ASQ Certified Quality Engineer and/or Certified Reliability Engineer
* Experience applying reliability statistics in capital equipment development and production
* MDD, CMDR and JPAL knowledge ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %; O=Occasional, R=Regularly, N=Never):

* Regularly walk, sit, and stand
* Occasionally bend and push/pull
* Occasionally lift over 25 pounds
* 15% travel potential
* Position dependent upon candidate passing pre-employment physical/drug screen All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity.

Associated topics: cellular, dsp, electrical, electrician, hardware, msee, plc, power, solar, stationary engineer

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