System Engineer – Design Controls

QvalFocus Inc. is seeking a System Engineer with strong Design Controls experience to support product development and remediation activities in a regulated medical device environment. The role focuses on ensuring clear traceability between user needs, design inputs, verification, and validation, while maintaining complete and compliant Design History Files (DHF).

Responsibilities:

• Support development and execution of design control processes for medical device products
• Ensure design activities follow FDA 21 CFR 820 and ISO 13485 requirements
• Establish and maintain traceability from user needs → design inputs → verification → validation
• Develop and maintain traceability matrices and supporting documentation
• Develop and maintain Design History Files ensuring design documentation is complete and inspection ready
• Ensure documentation clearly supports regulatory and internal requirements
• Support design verification and validation activities
• Ensure product requirements are verified and validated through proper test plans and documentation
• Work with hardware, software, quality, and regulatory teams during product development
• Support alignment between engineering development and regulatory requirements
• Prepare and maintain design control documentation, reports, and technical records
• Provide project updates on design activities, risks, and progress
• Identify opportunities to improve design control processes and traceability methods
• Support implementation of best practices in design documentation and compliance

Requirements:

• 5–8 years of experience in systems engineering or design engineering within a regulated industry, preferably medical devices
• Strong experience with Design Controls and DHF documentation
• Proven ability to maintain traceability between user needs, design inputs, verification, and validation
• Solid knowledge of FDA 21 CFR 820 and ISO 13485 requirements
• Strong documentation and technical writing skills
• Ability to work effectively in cross-functional engineering teams