Design Quality Engineer

The position leads design assurance activities for new product development, ensuring full compliance with FDA, ISO, and global medical device regulations. It drives quality engineering efforts across the product lifecycle, including risk management, verification/validation, and process validation, while supporting cross‑functional teams and suppliers.

Client Details

This company is a long‑established medical device innovator focused on advancing treatment for atrial fibrillation through endoscopically guided and pulsed field ablation technologies. Their portfolio includes multiple generations of balloon‑based ablation systems that provide direct visualization and precise energy delivery for cardiac procedures. The company also develops and manufactures systems used globally across hospitals and electrophysiology labs.

Description

• Ensure compliance with regulatory and quality standards during the design and development process.
• Collaborate with cross-functional teams to identify and resolve design-related quality issues.
• Conduct risk assessments and implement effective risk management strategies.
• Develop and maintain documentation for design control processes.
• Participate in design reviews and provide quality input to ensure product reliability.
• Support validation and verification activities for new products.
• Analyze quality data to identify trends and implement corrective actions.
• Stay updated on industry standards and regulations to ensure ongoing compliance.

Profile

A successful Design Quality Engineer should have:

• B.S. in a science or engineering field.
• 5+ years of quality management experience in medical devices or life sciences.
• Strong knowledge of design quality and regulatory standards.
• Experience with risk assessment and management in engineering and manufacturing processes.
• Proficiency in maintaining and developing design control documentation.
• Knowledge of validation and verification methodologies.

Job Offer

• Competitive salary ranging from $110,000 to $140,000 USD.
• Opportunities to work in a small-sized company.
• Potential for career growth and professional development.
• Engaging and supportive work environment.
• Comprehensive benefits package.

If you are passionate about ensuring design quality in engineering and manufacturing and are looking for a rewarding role, we encourage you to apply today!

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.