Quality Engineer, MedTech | Process & Compliance

AtriCure, Inc.; United States; On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical from day 1

401K with match

Parental Leave

Volunteer Time Off

Pet Insurance

On-site fitness center

Job summary

AtriCure, Inc. is seeking a Quality Engineer to support manufacturing operations and product lifecycle management. You will work with Engineering, Manufacturing, Regulatory, and Supplier Quality to maintain product quality, drive improvements, and ensure regulatory compliance.

The role requires a technical background and the ability to lead cross‑functional activities, including risk assessments and process validation. Strong communication and problem‑solving skills are essential.

Qualifications

• Strong problem-solving and troubleshooting abilities.
• Lean manufacturing tools knowledge (6S, Kaizen) a plus.
• Excellent interpersonal and communication skills.
• Familiarity with regulatory requirements (FDA, ISO 13485).
• Experience with Metrology and data analysis.
• Ability to interpret GD&T and process validation concepts.

Responsibilities

• Provide daily Quality Engineering support for manufacturing operations and address line issues using correction and prevention methods.
• Coordinate activities from Engineering, Manufacturing, Supplier Quality, Inspection, Document Control and related processes (NCR, Investigation, CAPA).
• Chair the MRB for respective product line and support risk management activities.
• Lead risk assessments, pFMEAs, health hazard evaluations, and risk control implementation.

Skills

Problem solving

Lean tools

Interpersonal skills

Communication

Regulatory knowledge

Gage R&R

Education

Bachelor’s degree in Engineering

Job description

AtriCure, Inc. is seeking a Quality Engineer to support manufacturing operations and product lifecycle management. You will work with Engineering, Manufacturing, Regulatory, and Supplier Quality to maintain product quality, drive improvements, and ensure regulatory compliance.

The role requires a technical background and the ability to lead cross‑functional activities, including risk assessments and process validation. Strong communication and problem‑solving skills are essential.