Design Assurance Engineer in Saint Paul

Essential Job Duties & Skills

• 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 traceability 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.