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:
ยท Work with the product development team(s) in conducting risk analysis activities such as Design FMEAs, Process FMEAs, Hazard Analysis, and User Risk Analysis.
ยท Manage tracability of design requirements through risk mitigation and design verification
ยท Technical writing and critical review of design verification plans, procedures, test protocols and reports.
ยท Critical review of design and process documents and records such as procedures, specifications, drawings and various Design History File records
ยท Lead key equipment qualification efforts
ยท Lead supplier management activities
ยท Review and evaluate non-conforming materials.
ยท Work with vendors to correct material non-conformances
ยท Generate inspection procedures for both incoming parts and on-site production.
ยท Review manufacturing documentation for accuracy and clarity.
ยท Contribute to process validation activities
ยท Proficient knowledge and use of applicable industry standards specifically, ISO 13485 for Quality Systems, and ISO 14971 for Risk Management
ยท Proficient in MS Office Suite including but not limited to MS Outlook, MS Word MS Excel, MS PowerPoint.
Additional Job Expectations:
ยท Being aligned with team goals and supportive in a team environment
ยท Sound communication in collaborations with other company functions (written and verbal)
ยท Using good judgment when confronted with choices
ยท Being organized, thorough in prioritizing and generating work products
ยท Being both proactive and professional
Education and Experience:
ยท BS in Mechanical Engineering or a related field
ยท 5+ years of Design Assurance in Life Sciences Industry
IVD medical device environment a plus
ยท Experience with statistical methods and terminology
ยท Demonstrated structured problem-solving skills