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 medical devices.
- Collaborative environment and career development.
- Comprehensive benefits, including medical, dental, vision, retirement, PTO, parental leave, and disability support
