ECO Management Engineer

Location: 100% On Site, Tel Aviv, Israel

Residency: Israel

Employment: One-year contract, option to become Full-time

Client: Oriel STAT A MATRIX (https://orielstat.com)

Industry: Medical Devices

In this role, the ECO Management Engineer will provide extensive knowledge of the Product Lifecycle Management for a medical device manufacturer. The candidate will provide independent judgment in the utilization of ECO management methods, techniques, and evaluation criteria for establishing and implementing the engineering change process including managing the requirements and operational information throughout the product lifecycle. This position interfaces with cross-functional teams and SMEs to complete formal approval and release of product deliverables while implementing engineering change control activities to ensure the company remains compliant throughout the lifecycle of the medical products.

In this role, the candidate will be responsible for driving engineering change management and will include the following:

• Effectively manage and oversee all Engineering Change Orders (ECOs).
• Review all ECOs at the design stage and liaise with R&D Engineers and other team members to optimize the content before release to manufacturing.
• Coordination and planning of ECOs before production implementation (transfer to manufacturing).
• Ensure all design work follows the recommended R&D workflows and engineering guidelines.
• Review and sign off on technical drawings before release to manufacturing.
• Continued management of ongoing improvements and refinement of the Design ECO process.
• Create and update Standard Operating Procedures (SOPs) for the Design and Development ECO process.
• Proofreading and technical verification of internal and customer-facing documentation before release.
  
  

• Confident personality and competent in getting ideas across to others effectively
• Demonstrates ability to work in a team environment, especially when operating remotely
• Respect the contribution of all colleagues and facilitate consensus on tough issues
• Ability to assimilate diverse data, think critically, and solve problems
  
  

• Bachelors degree in Engineering, Science, or life sciences related field, masters preferred.
• Evidence of progressively taking more responsibility and leading activities in management or as a high-level individual contributor
• A minimum of seven years leading medical engineering projects
• End-to-end project lifecycle experience with medical device manufacturing
  
  

• Experience with medical device manufacturing, interpretation, and application of codes, regulations, and standards
• Experience with quality systems planning and implementation, design control, and process validation
• Experience with FDA 21 CFR Part 803, FDA 21 CFR 11, & FDA 21 CFR Part 820 and/or relevant EU Regulations