Senior Quality Engineer, Contract Manufactured Product
As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, electrophysiologists and cardiothoracic surgeons around the globe count on AtriCure to deliver best-in-class solutions that can treat even the most complex cases. Our Isolator® Synergy™ Ablation System is the first and only medical device approved by the FDA for the treatment of long standing persistent Afib, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, and we are expanding into pain management therapies. We invest in innovation, clinical science, and education to focus on improving lives for our patients’ worldwide.
This Senior Quality Engineer, Contract Manufactured Product role works closely with Contract Manufacturers, AtriCure engineering, manufacturing, 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. The job performance requires advanced technical abilities as well as an understanding of product design, manufacturing and quality systems.
ESSENTIAL FUNCTIONS OF THE POSITION:
Provides Quality Engineering support for products generally acquired as finished devices (less some value-added operations).The products within this category will require routine collaboration with key contract manufacturers, suppliers and internal functions.Daily tasks require the timely addressing of product line issues through correction and prevention processes.
With respect to direct product responsibility, the Sr QE for Contract Manufactured Product manages, and coordinates required activities from external (contractor and supplier) and internal functions (ie. Engineering, Manufacturing, Quality, Inspection, Document Control) and processes (ie. Product qualification, process validation, NCRs, FMEA’s, Rework, Deviations)
Chairs the 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
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.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Regular and predictable worksite attendance [removed for field-based jobs]
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
Bachelor’s degree in Engineering required or demonstrated equivalent combination of education, training and experience
5+ years of experience
Knowledge/experience working with contract manufacturers of finished devices.
Knowledge/experience with sterile packaging of disposable medical devices.
Knowledge/experience with EO and Gamma sterilization validation and continuous monitoring.
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
Data analysis experience
Computer/data entry skills
Written/report writing skills
Experience with industrial or manufacturing statistics
Ability to travel 25%
MDD, CMDR and JPAL knowledge
ASQ Certified Quality Engineer and/or Auditor
Experience training production associates, inspectors, and training/mentoring junior engineers.
Ability to regularly walk, sit, or stand as required
Ability to occasionally bend and push/pull
Ability to occasionally lift up to 25 pounds
Ability to pass pre-employment drug screen and background check
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, 15 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/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).
- Job Family Quality Engineering
- Job Function Quality
- Pay Type Salary
- Employment Indicator Non Manager