Design Quality Engineer

Design Quality Engineer Advantage Technical - 3.7 Carlsbad, CA Job Details Temporary | Full-time $50 - $64 an hour 20 hours ago Benefits Paid holidays Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Medical device validation Quality risk management Leading team collaboration initiatives Design controls Biomedical regulatory compliance Cross-functional team management

ISO 13485

Cross-functional communication Engineering quality assurance

Full Job Description Pay:

$50.00-$64.00/hr

Schedule:

Regular Business Hours Location:

Carlsbad, CA Position Type:

Temporary Make a meaningful impact on patient care as a Design Quality Engineer III supporting new product development and commercialized medical devices. Advantage Technical is partnering with a leading medical device manufacturer in Arden Hills, MN to place a senior-level design assurance engineer in a high-visibility, cross-functional role. What You'll Do Lead risk management activities including hazard analysis, fault tree analysis, and FMEAs in alignment with

ISO 14971

Develop and approve V&V protocols and reports using advanced statistical techniques Provide quality engineering support on NPD teams — design inputs, verification and validation strategies, and regulatory compliance Establish and maintain Design History File documentation, ensuring inspection readiness Execute design change control, assess product/process impacts, and ensure patient safety compliance Monitor field performance, analyze trends against risk assessments, and drive CAPA as needed Mentor junior engineers and contribute to team best practices What You Bring (Experience and Qualifications) BS in Engineering or related technical field 3+ years in quality engineering or design assurance within medical devices Expertise in risk management, design controls, and V&V Strong knowledge of ISO 13485 and

ISO 14971

Proven ability to lead cross-functional initiatives and influence stakeholders Candidates must be local and authorized to work in the U.S. without visa sponsorship now or in the future.

Preferred Qualifications:

Biomedical or mechanical engineering degree preferred Structural heart, cardiovascular, or implantable device experience a plus CQE certification a plus

Benefits:

Competitive weekly pay Weekly direct deposit Medical, dental, vision, and life insurance Optional 401(k) Take the first step toward your next opportunity. Apply now. The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs. About Us Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies. Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.