Design Assurance EngineerZipRecruiter • Saint Paul, MN, US
Design Assurance Engineer
ZipRecruiter • Saint Paul, MN, US
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job_description.job_card.job_descriptionBeing 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; IV D medical device environment a plus Experience with statistical methods and terminology Demonstrated structured problem-solving skills
Overview
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.
Responsibilities
- 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
Education and Experience
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Design Assurance Engineer • Saint Paul, MN, US