Quality Engineer - Medical Devices, Continuous Improvement

AtriCure, Inc.; Mason (OH); On-site; USD 75,000 - 115,000; Full time

Benefits offered by this job

Medical & Dental from day 1

401K with company match

Parental Leave (30 days)

Volunteer Time Off

Pet Insurance

Job summary

AtriCure, Inc. is seeking a Quality Engineer to support manufacturing operations and product lifecycle management.

You will collaborate with Engineering, Manufacturing, Regulatory, and Supplier Quality to ensure quality, risk management, and regulatory compliance across products and processes. The role requires a technical foundation to lead daily activities, drive improvements, and participate in design assurance and transfer projects.

Qualifications

• Bachelor's degree in Engineering or 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 (GD&T) and product specifications.
• Measurement System Analysis (Gage R&R) experience is a plus.
• Experience with process validation, design verification/validation.
• Problem solving/troubleshooting experience.
• Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kaizen.
• 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.

Responsibilities

• Provides daily Quality Engineering support of manufacturing operations with cross-functional teams.
• Coordinates activities from Engineering, Manufacturing, Supplier Quality, Inspection, Document Control.
• Chairs the MRB for respective product line.
• Leads risk management activities including pFMEAs and health hazard evaluations.
• Analyzes quality metrics and process performance to drive improvements.
• Supports design assurance and NPD teams with inspection/control plans.
• Develops and approves process validation, equipment qualification, and test method validation.
• Contributes to quality system processes and regulatory requirements.
• Assists with FDA and ISO audits as necessary.
• Adapts to shifting priorities and resolves problems with minimal guidance.

Skills

Problem solving

Lean Manufacturing

Communication skills

Interpersonal skills

Data analysis

Gage R&R

Education

Bachelor's degree in Engineering

Equivalent combination of education/training/experience

Job description

AtriCure, Inc. is seeking a Quality Engineer to support manufacturing operations and product lifecycle management.

You will collaborate with Engineering, Manufacturing, Regulatory, and Supplier Quality to ensure quality, risk management, and regulatory compliance across products and processes. The role requires a technical foundation to lead daily activities, drive improvements, and participate in design assurance and transfer projects.