Design Quality Engineer

The Design Quality Engineer leads design assurance and quality activities across the product lifecycle to ensure compliance with FDA, ISO 13485, and EU MDR requirements for Class III medical devices. This role supports NPI efforts, provides technical guidance to engineering teams, and drives high standards in risk management, validation, and supplier quality.

Client Details

The company is a long‑established medical device innovator focused on advancing minimally invasive solutions for treating complex cardiac rhythm disorders, with a strong record of developing FDA‑approved technologies used globally. It combines deep R&D expertise with a commitment to improving clinical outcomes, contributing to the evolution of next‑generation treatment options within cardiac electrophysiology.

Description

Lead Design Assurance activities across all phases of product development.

Provide expertise in:

• Risk Management
• Design Verification & Validation
• Test Method Validation (TMV)
• Statistical analysis and tools
• Process Validation (PV)
• Design Control processes
• Apply structured problem‑solving to address product and process quality issues.
• Monitor and interpret regulatory requirements relevant to Class III devices.
• Mentor and provide guidance to engineering and project teams.
• Support supplier qualification and quality assessments.
• Assist in establishing and optimizing pilot production processes.
• Perform additional quality-related responsibilities as needed.

Profile

• Bachelor's degree in Engineering or a related scientific discipline.
• 5+ years of experience in Quality Engineering or Quality Management within the medical device or life sciences industry.
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and relevant medical device regulatory requirements.
• Experience with Class III medical devices; exposure to cardiac electrophysiology devices is a strong plus.

Job Offer

• Competitive salary ranging from $110000 to $140000 USD annually.
• Comprehensive benefits package.
• Opportunities for professional development and growth.
• A collaborative and supportive work environment.

If you are a motivated Design Quality Engineer looking to advance your career in the business services industry, we encourage you to apply and join a company that values quality and innovation.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.