Principal Design Quality Engineer (Maple Grove)

Principal Design Quality Engineer Location:

Maple Grove, MN (Weaver Lake Campus) Work Schedule:

Hybrid – Minimum 3 days per week onsite Pay Rate:

Up to $78.00 an hour or about $159,000 a year Contract Length:

12 months; potential temp-to-hire based on performance and budget Work Authorization:

Applicants must be authorized to work in the U.S. without current or future visa sponsorship. Sponsorship is not available for this role.

About the Role This company is seeking a

Principal Design Quality Engineer

to support development projects within the Cardiology division. This is a high-visibility position supporting a major product category. The role will leverage deep expertise in Design Controls to evaluate the health of existing Design History Files (DHFs) and assess remediation needs in collaboration with cross-functional teams.

Key Responsibilities Apply advanced knowledge of Design Controls and Risk Management to provide quality and compliance guidance to project teams. Assess the adequacy of test method validation coverage, documentation, and execution. Independently and cross-functionally evaluate design requirements and risk controls within Design History File documentation, including user needs, hazard analyses, and design verification deliverables. Utilize systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Ensure commitment to patient safety and product quality through adherence to Quality Policy and documented quality procedures.

Required Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related engineering field Minimum 8 years of experience in design assurance, quality engineering, or related role within medical device or regulated industry Strong experience in new product development, including: Risk management plans/reports Hazard analysis, task analysis, DFMEA Test method validation Design requirements Design verification and validation Demonstrated knowledge and application of ISO 13485, ISO 14971, CFRs, and Quality System Regulations Strong organizational, planning, and results-driven mindset Excellent verbal and written communication skills Proven experience using quality tools and methodologies

Preferred Qualifications Experience developing test methods Strong problem-solving skills and ability to facilitate structured problem-solving processes Effective collaborator in both team-based and independent work environments Experience working with global cross-functional teams (R&D, Process Development, Manufacturing, etc.) Experience with Class III medical devices