Job Title: Quality Engineer Job Description We are seeking a skilled Quality Engineer to join our team and contribute engineering solutions in Design Assurance, Design Controls, Risk Management, and Statistical Techniques. This role is integral to our new product development, ensuring compliance and driving improvements in world-class manufacturing. 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 and regulations, including plans and hazard analyses. + 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. Essential Skills + Proficiency in Design Assurance, Design Controls, and Test Method Development. + Experience working with catheters in a startup environment. + Hands-on experience in a regulated industry. + Experience supporting audits, equipment and calibration, updating work instructions and SOPs, change orders, IQ, TFIQ, and release of equipment. + Knowledge of Software Development Life Cycle Processes (IEC) and Usability Engineering Processes (IEC). Additional Skills & Qualifications + Bachelor’s degree in engineering or related field with 4 years of relevant experience, or Master’s degree with 2 years of experience. + Experience working with suppliers. + Must be open to working in a clean room environment. Work Environment This is an onsite position within a collaborative environment that includes roles such as Sr Quality Manager, Software Engineer, Doc Control, Quality Intern, and QC. Our work environment offers impactful work in the medical device industry, career development, and comprehensive benefits including medical, dental, vision, 401(k), PTO, and disability support. Pay and Benefits The pay range for this position is $105000.00 - $125000.00/yr. will confirm benefits on req qual Workplace Type This is a fully onsite position in Carlsbad,CA. Application Deadline This position is anticipated to close on Aug 4, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.