Design Assurance Engineer

Overview

The Design Assurance Engineer provides critical quality and regulatory oversight to ensure that all design and development activities for our medical devices comply with internal quality requirements and external regulatory standards, including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and ISO 14971. This role is essential for guiding the design control process, managing the risk management file, and ensuring the integrity of the Design History File (DHF).

• Provide guidance and approval for all design control documents, ensuring design inputs, outputs, verification, validation, and changes are properly documented and meet regulatory requirements
• Lead and participate in risk management activities (e.g., Hazard Analysis, DFMEA, UFMEA) from product concept through commercialization to ensure appropriate risk mitigation and documentation in the risk management file
• Develop, review, and support the execution of design verification and validation plans, protocols, and reports, including test method development and validation activities
• Oversee the creation, maintenance, and review of the Design History File (DHF) to ensure completeness, accuracy, and compliance with all applicable standards and regulations
• Work closely with R&D, manufacturing, regulatory affairs, clinical, and supplier quality teams to integrate quality and compliance activities throughout the product lifecycle
• Support internal and external regulatory audits (e.g., FDA, Notified Bodies) and participate in root cause analysis, CAPA (Corrective and Preventive Action), and non-conformance investigations
• Utilize statistical methods and analysis tools (e.g., Minitab) for data analysis, reliability studies, and determining appropriate sample sizes for testing and validation activities
• Support the transfer of new products from development to manufacturing, ensuring a seamless and compliant transition

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related technical field) or equivalent discipline is require
• 5+ years of experience in Quality Assurance or Quality Engineering within the medical device industry
• Proven experience with Design Controls, Risk Management (ISO 14971 and 13485), Process Validation, and statistical methods
• Strong knowledge of medical device regulations and standards (e.g., 21 CFR 820, ISO 13485)
• Strong understanding of quality science principles, including acceptance sampling, SPC, DOE, and root cause analysis
• ASQ Certified Quality Engineer (CQE) or Certified Quality Manager (CMQ-OE) is highly desirable
• Able to function with urgency in high-pressure situations
• Excellent verbal, written communication, especially with development and quality teams
• Demonstrated business acumen with the proven ability to work independently as well as collaboratively in a cross-functional team environment
• Early stage/start up experience strongly preferred