Principal Design Quality Engineer ::::: Maple Grove, MN

Principal Design Quality Engineer

Location: Hybrid Maple Grove, MN (Onsite at least 3 days/week)

Position Overview

A leading medical device organization is seeking a Specialty Engineering Professional to support design quality activities within a high visibility product category. This role focuses on evaluating the health of existing design history files, assessing risk management documentation, and identifying areas requiring remediation. The engineer will collaborate cross functionally and apply strong design control expertise to ensure compliance with regulatory and quality system requirements.

This hybrid role requires at least three days per week onsite at the Maple Grove, MN campus.

Key Responsibilities

• Apply in depth knowledge of Design Controls and Risk Management to support ongoing design quality initiatives.
• Provide quality and compliance input to cross functional project teams.
• Assess adequacy of test method validation documentation, coverage, and execution.
• Independently evaluate design requirements, risk controls, and design history file content for completeness and compliance.
• Review user needs, hazard analyses, design verification deliverables, and related documentation.
• Utilize systematic problem solving methodologies to identify, prioritize, and resolve quality issues.
• Maintain strict adherence to all quality policies, procedures, and regulatory expectations.
• Support audits, reviews, and remediation activities as needed.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• Minimum 8 years of experience in design assurance, quality engineering, or a regulated medical device environment.
• Strong background in new product development, including:
• Risk management deliverables (risk plans/reports, hazard analysis, task analysis, DFMEA, etc.)
• Test method validation
• Design requirements development
• Design verification and validation
• Working knowledge of ISO 13485, ISO 14971, FDA Quality System Regulations, and related standards.
• Excellent organizational, planning, and communication skills.
• Demonstrated experience using quality tools and methodologies.

Preferred Qualifications

• Experience developing test methods and facilitating structured problem solving.
• Ability to work effectively in both team based and self directed environments.
• Experience collaborating with global teams across R&D, process development, manufacturing, and related functions.
• Background working with Class III medical devices.

Additional Notes

• The selected candidate will work closely with a team of approximately 10 individuals at the site.
• Candidates must be proficient in Minitab.