Control Design Engineer

Location: Remote – USA

Employment Type: Full-time

Key Responsibilities

• Support design control activities throughout the medical device product lifecycle.
• Prepare, review, and maintain Design History Files (DHF) and design documentation.
• Develop and maintain design inputs, design outputs, and traceability matrices.
• Support design reviews and document design changes in accordance with established procedures.
• Assist with design verification and validation (V&V) activities, including protocols, testing, and reports.
• Support risk management activities in accordance with ISO 14971.
• Maintain traceability between user needs, design inputs, outputs, verification, and validation evidence.
• Support design change control, engineering changes, and documentation updates.
• Collaborate with R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and Engineering teams.
• Identify documentation gaps and support remediation of design control records.
• Ensure compliance with FDA regulations, ISO 13485, and applicable quality system requirements.
• Support internal audits, regulatory inspections, and design control process improvements.

Requirements & Tech Stack

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Biotechnology, or a related field.
• 0-2 years of experience in design controls, quality engineering, design assurance, or medical device engineering.
• Knowledge of FDA design control requirements, ISO 13485, and ISO 14971.
• Experience with DHF documentation, design inputs/outputs, and requirements traceability.
• Understanding of design verification, validation, risk management, and change control.
• Strong technical writing, documentation, analytical, and communication skills.