Medical Device Quality Engineer: Manufacturing & Compliance

Atricure,-Inc; Mason (OH); On-site; USD 70,000 - 105,000; Full time

Benefits offered by this job

Medical & Dental

401K with matching

Paid parental leave

Volunteer time off

Pet Insurance

Job summary

AtriCure, Inc. seeks a Quality Engineer to be the primary quality representative supporting manufacturing operations and product lifecycle management.

You will collaborate with Engineering, Manufacturing, Regulatory and Supplier Quality to ensure product quality, risk management, and regulatory compliance of AtriCure products and processes. This role requires a technical foundation and the ability to lead cross‑functional activities from daily operations through process validation, design

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.
• Experience training production associates, inspectors, or junior engineers.
• Experience with industrial or manufacturing statistics.

Responsibilities

• Provides daily Quality Engineering support of manufacturing operations where daily activities require working with cross‑functional teams.
• Manages and coordinates activities from Engineering, Manufacturing, Supplier Quality, Inspection, Document Control and processes (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.
• Analyzes quality metrics, manufacturing trends, and process performance indicators to identify risks and drive improvements.
• Supports new product development and transfer by assisting Design Assurance and NPD teams with inspection/control plans and production controls.
• Leads and/or supports protocol development, execution, review and approval for process validation, equipment qualification, and test method validation.
• Contributes to quality system processes and regulatory compliance.
• Assists with FDA and ISO audits as necessary.
• Adapts to shifting priorities and resolves problems with minimal guidance.

Skills

Interpersonal skills

Organization

Communication

Problem solving

Lean manufacturing

Education

Bachelor's degree in Engineering

Tools

Gage R&R

Job description

AtriCure, Inc. seeks a Quality Engineer to be the primary quality representative supporting manufacturing operations and product lifecycle management.

You will collaborate with Engineering, Manufacturing, Regulatory and Supplier Quality to ensure product quality, risk management, and regulatory compliance of AtriCure products and processes. This role requires a technical foundation and the ability to lead cross‑functional activities from daily operations through process validation, design