Systems Engineer – Design Controls

Intellectt Inc is seeking an experienced Systems Engineer with expertise in Design Controls within regulated medical device environments. This role involves supporting product development by ensuring compliance with quality and regulatory requirements throughout the design lifecycle, while collaborating cross-functionally with various teams.

Responsibilities:

• Support Design Controls activities for medical device product development projects
• Maintain traceability between user needs, design inputs, risk controls, verification, and validation activities
• Assist with Design Verification & Validation (V&V) planning, execution, and documentation
• Develop and maintain Design History Files (DHF), trace matrices, protocols, and reports
• Collaborate with cross-functional teams including Engineering, Quality, and Regulatory Affairs
• Ensure compliance with FDA regulations, ISO standards, and internal quality processes
• Participate in risk management and product lifecycle activities
• Support remediation, compliance, and process improvement initiatives as needed

Requirements:

• 5–8 years of Systems Engineering experience in medical device or regulated industries
• Strong experience with Design Controls, traceability, and V&V activities
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and regulated product development processes
• Experience supporting cross-functional engineering and quality teams
• Strong documentation, communication, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment
• Experience with ISO 14971 risk management activities
• Familiarity with requirements management and traceability tools
• Knowledge of regulatory documentation and compliance practices
• Prior experience supporting remediation or quality improvement projects