Energy Jobline ZR
Design Assurance Engineer in Saint Paul
Energy Jobline ZR, Saint Paul, Minnesota, United States, 55199
Overview
Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide.
We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
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; IV medical device environment a plus
Experience with statistical methods and terminology
Demonstrated structured problem-solving skills
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
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We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
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; IV medical device environment a plus
Experience with statistical methods and terminology
Demonstrated structured problem-solving skills
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr