Quality Engineer

Summary

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Quality Engineer serves as the primary quality representative supporting manufacturing operations and product lifecycle management, coordinating cross-functional activities related to product quality, risk management, continuous improvement, and regulatory compliance. The role also supports process validation, new product development and transfer, quality systems, and FDA and ISO audits.

Responsibilities

• 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
• 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

Skills

• * 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
• * Ability to regularly walk, sit, or stand as needed
• * Ability to occasionally bend and push/pull as needed
• * 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

Qualifications

Must Haves

• * 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
• * Ability to regularly walk, sit, or stand as needed
• * Ability to occasionally bend and push/pull as needed

Nice to Haves

• * 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

Benefits

• For US based employees and their families: Medical & Dental beginning day 1 of employment
• For US based employees and their families: 401K plus match
• For US based employees and their families: 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads
• For US based employees and their families: Volunteer Time off
• For US based employees and their families: Pet Insurance
• Corporate-based employees also have full access to our on-site fitness center and cafeteria