Design Assurance Engineer

Job Description

Design Assurance engineer to represent the Quality function on a product development team. This engineer would be a key contributor to risk management and design verification planning and execution. Secondarily, this position would also provide support for supplier management and material quality activities.

• Work with the product development team(s) in conducting risk analysis activities such as Design FMEAs, Process FMEAs, Hazard Analysis, and User Risk Analysis.
• Manage tracability of design requirements through risk mitigation and design verification
• Technical writing and critical review of design verification plans, procedures, test protocols and reports.
• Critical review of design and process documents and records such as procedures, specifications, drawings and various Design History File records
• Lead key equipment qualification efforts
• Lead supplier management activities
• Review and evaluate non-conforming materials.
• Work with vendors to correct material non-conformances
• Generate inspection procedures for both incoming parts and on-site production.
• Review manufacturing documentation for accuracy and clarity.
• Contribute to process validation activities
• Proficient knowledge and use of applicable industry standards specifically, ISO 13485 for Quality Systems, and ISO 14971 for Risk Management
• Proficient in MS Office Suite including but not limited to MS Outlook, MS Word MS Excel, MS PowerPoint.

• Being aligned with team goals and supportive in a team environment
• Sound communication in collaborations with other company functions (written and verbal)
• Using good judgment when confronted with choices
• Being organized, thorough in prioritizing and generating work products
• Being both proactive and professional

• BS in Mechanical Engineering or a related field
• 5+ years of Design Assurance in Life Sciences Industry
  IVD medical device environment a plus
• Experience with statistical methods and terminology
• Demonstrated structured problem-solving skills