Role: Senior Design Quality Engineer
Location: MN
Duriation: 12 months
Rate: $45-50 Hr on W2
Overview
We are seeking a Senior Design Quality Engineer to provide Design Quality Assurance support for medical device products and engineering initiatives. This individual will partner closely with R&D, Manufacturing, Regulatory, and Operations teams to ensure product changes, engineering activities, and design control deliverables are compliant with internal quality systems and applicable regulatory requirements.
The ideal candidate is a hands-on Design Quality professional who can take high-level direction, independently work through technical documentation, engineering drawings, procedures, and historical records, and provide quality guidance throughout product lifecycle activities. This role will support projects involving material replacements, CAPA investigations, Design History File updates, test method development, risk assessments, and design control documentation.
Key Responsibilities
Serve as the Design Quality representative on cross-functional engineering and product development initiatives.
Provide quality oversight and guidance for design changes, product improvements, remediation efforts, and engineering investigations.
Review and approve design control deliverables including requirements, design inputs/outputs, verification protocols, reports, risk management documentation, and traceability matrices.
Support material replacement projects, engineering changes, and product modifications while ensuring compliance with applicable quality and regulatory requirements.
Participate in CAPA investigations, root cause analysis, effectiveness reviews, and implementation of corrective actions.
Review and assess engineering drawings, specifications, design matrices, procedures, and technical documentation for compliance and quality impact.
Support Test Method Development (TMD), verification activities, protocol reviews, and validation documentation.
Maintain and support Design History File (DHF) documentation and design records.
Partner with R&D teams to ensure design controls are effectively applied throughout the product lifecycle.
Facilitate risk management activities including risk assessments, hazard analysis, and design-related risk evaluations.
Analyze quality and engineering data, summarize findings, and communicate recommendations to project teams and leadership.
Support compliance with applicable medical device regulations, standards, and internal quality system requirements.
Lead or support continuous improvement initiatives focused on design quality processes and product quality outcomes.
Required Qualifications
Bachelor's degree in Engineering or related technical discipline.
4+ years of medical device experience in Design Quality Assurance, Quality Engineering, or R&D Engineering.
Experience supporting single-use medical devices and design control activities.
Strong knowledge of:
Design Controls
Design History Files (DHF)
CAPA Processes
Risk Management
Design Verification
Engineering Drawings and Prints
Design Matrices and Traceability
Test Method Development (TMD)
Technical Documentation and Report Writing
Ability to independently investigate issues, navigate technical documentation, and drive projects with minimal supervision.
Strong communication and cross-functional collaboration skills.
Preferred Qualifications
Prior Design Quality Assurance experience supporting R&D organizations.
Experience supporting packaging and labeling changes.
Experience using Windchill PLM.
Knowledge of medical device standards including:
ISO 10555
ISO 80369
IEC 60601
Experience supporting electro-mechanical medical devices.
Mechanical or Electrical Engineering background with exposure to product development activities.
Familiarity with systems-level documentation and requirements management.
Previous experience reviewing or supporting Design History Files, design reviews, verification activities, and risk management documentation.