Design Assurance Engineer

Overview

We are seeking a Senior Design Assurance Engineer with extensive experience in medical device quality engineering, design controls, and risk management to support critical quality and remediation initiatives. This role will provide quality engineering leadership for design assurance activities, support ISO gap assessments, and ensure compliance with FDA and ISO requirements throughout the product lifecycle.

The ideal candidate will have a strong background in Design History Files (DHFs), design verification, risk management, and ISO remediation projects within the medical device industry.

• Provide quality engineering support for new product development and sustaining engineering activities
• Lead Design Assurance activities in accordance with FDA and ISO 13485 requirements
• Review and maintain Design History Files (DHFs), Design Matrices, engineering drawings, and design documentation
• Support Design Controls throughout the product development lifecycle
• Review design verification documentation and ensure compliance with applicable standards
• Participate in ISO gap assessments and remediation activities
• Perform risk management activities in accordance with ISO 14971
• Collaborate with Engineering, Quality, Regulatory Affairs, and Manufacturing teams
• Support internal and external audits while ensuring documentation is inspection-ready
• Drive continuous improvement initiatives and quality system enhancements

• Bachelor's degree in Engineering or related technical discipline
• 10+ years of Design Assurance or Quality Engineering experience within the Medical Device industry
• Extensive experience with Design Controls and Design Verification
• Strong experience supporting Design History Files (DHFs)
• Experience reviewing Design Matrices, engineering prints, and technical documentation
• Hands-on experience supporting ISO standards gap assessment or remediation projects
• Strong understanding of ISO 14971 Risk Management
• Knowledge of FDA Quality System Regulations and ISO 13485
• Excellent communication and cross-functional leadership skills

• Experience supporting FDA inspections and regulatory audits
• Experience with New Product Development (NPD)
• ASQ Certified Quality Engineer (CQE) certification

Compensation is based on experience.

This is a contract position and does not include employer-provided benefits.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background checks may be conducted in accordance with applicable laws.

Applicants must be authorized to work in the United States.