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.
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 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.
Additional Job Expectations:
· 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
Education and Experience:
· 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
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