Job Details

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