System Engineer – Design Controls (Med Device)

Shoolin Inc is seeking a System Engineer with strong experience in Design Controls to support product development activities in a regulated medical device environment. The role focuses on maintaining design traceability, supporting verification and validation activities, and ensuring compliant Design History File (DHF) documentation throughout the product development lifecycle.

Responsibilities:

• Support development and execution of design control processes for medical device products
• Ensure design activities follow regulatory requirements including FDA 21 CFR 820 and ISO 13485
• Establish and maintain traceability from user needs through design inputs, verification, and validation
• Develop and maintain traceability matrices and related documentation
• Maintain Design History Files (DHF) ensuring documentation is complete and inspection ready
• Support design verification and validation activities and ensure proper test documentation
• Collaborate with hardware, software, quality, and regulatory teams during product development
• Prepare and maintain design control documentation, reports, and technical records
• Support continuous improvement of design control processes and documentation practices

Requirements:

• 8+ years of experience in systems engineering or design engineering within a regulated industry, preferably medical devices
• Strong experience with Design Controls and Design History File (DHF) documentation
• Proven experience maintaining traceability between user needs, design inputs, verification, and validation
• Solid knowledge of FDA 21 CFR 820 and ISO 13485
• Strong technical documentation and writing skills