Quality Engineer, New Product Development

Quality Engineer, New Product Development

Carlsbad - US

What we value:

• Honesty & Integrity: Uphold ethical standards and a strong work ethic.
• Passion & Curiosity: Show enthusiasm for medical device engineering and continuous learning.
• Problem Solving & Learning Ability: Demonstrate problem-solving skills and seek professional growth.

Key responsibilities:

• Provide engineering solutions in Design Assurance, Design Controls, Risk Management, and Statistical Techniques.
• Lead design assurance and development activities, including engineering studies, feasibility testing, and drawing reviews for new product development.
• Create and maintain risk management files per ISO 14971 and regulations (plans, hazard analyses, FMEAs, etc.).
• Develop quality assurance specifications, test methods, inspection procedures, and sampling plans.
• Lead test method development and validation.
• Support new product launch, validation, and design transfer into manufacturing.
• Address production issues and drive improvements for compliance and world-class manufacturing.
• Implement and review changes to products, SOPs, and other documentation for regulatory submissions.
• Support supplier evaluation and qualification.

What we are looking for:

• Bachelor's degree in engineering or related field with 4 years of relevant experience, or Master's degree with 2 years of experience.
• Hands-on experience with Design Assurance, Design Controls, and Test Method Development.
• Experience in a regulated industry.
• Highly Preferred knowledge of Software Development Life Cycle Processes (IEC 62304) and Usability Engineering Processes (IEC 62366).

What we offer:

• Impactful work in the medical device industry.
• Collaborative environment and career development.
• Comprehensive benefits, including medical, dental, vision, 401(k), PTO, and disability support.