Seeking a Design Assurance Engineer with 2-5 years of experience, preferably in the medical device industry, to support new product development, design controls, risk management, and regulatory compliance.

Key Responsibilities:

• Ensure design verification and validation activities meet regulatory requirements.
• Support new product development and sustaining engineering projects, ensuring compliance with FDA QSR, ISO 13485, and ISO 14971.
• Collaborate with R&D, Regulatory, and Quality teams to manage design risk and test method validation.
• Lead Health Risk Assessments for market products and evaluate design change impacts.
• Assess and document design inputs, usability, reliability, and biocompatibility standards.

Qualifications:

• Bachelor’s degree in a technical field.
• 2-5 years experience in medical devices or regulated industry.
• Strong knowledge of design control, risk management, and regulatory requirements (FDA, ISO 13485, ISO 14971).
• Experience with verification & validation, root cause failure analysis, and statistical methods.
• Ability to work cross-functionally and manage compliance documentation.

Preferred Skills:

• Experience with test method validation, DOE, and failure analysis.
• Familiarity with sterilization, packaging, and software validation.