Application:

    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.