Job Description
Job Description
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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