Job Information
Advantage Technical Services, Inc Principal Design Quality Engineer in Maple Grove, Minnesota
Principal Design Quality Engineer - Cardiology Location: Maple Grove, MN (Hybrid - minimum 3 days/week onsite at Weaver Lake Road campus) Pay Rate: Up to $78/hour We are hiring a Principal Design Quality Engineer to support high-visibility development projects within a leading Cardiology division. This role focuses on design controls, risk management, and design history file (DHF) remediation for complex medical devices. This is an excellent opportunity for an experienced medical device quality engineer with strong expertise in ISO 13485, ISO 14971, CFRs, Quality System Regulations, and Class III medical devices. Key Responsibilities: Apply advanced Design Control and Risk Management principles to product development initiatives Evaluate and remediate Design History Files (DHF) Assess design requirements, risk controls, hazard analyses, and verification/validation documentation Validate and assess test method development and execution Drive quality improvements using structured problem-solving methodologies Partner cross-functionally with R&D, Manufacturing, and Process Development teams Required Qualifications: Bachelor's degree in Mechanical, Biomedical, or related Engineering field 8+ years in design assurance, quality engineering, or regulated medical device environments Experience with risk management deliverables (DFMEA, hazard analysis, risk plans/reports) Strong written and verbal communication skills Employee Benefits Medical, dental, vision, and pet insurance 401(k) Retirement Savings Plans Employee Assistance Program (EAP) Commuter/Parking Accounts People Perks Health Savings Account (HSA) AD & D Insurance Applicants must be authorized to work in the U.S. without visa sponsorship now or in the future. If you're a results-driven quality leader ready to impact innovative cardiology products, click "Apply Now" to be considered. 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. After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. 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. Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, intervi wing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.