Mechanical Engineer

Position's Scope:

The Manufacturing Engineer has a critical role within the Engineering Department, responsible for driving continuous improvement and operational excellence in the production line. This position demands a highly motivated and technically skilled engineer with a deep understanding of the Assembly Process, Integration Process, Calibration Process, Process Validation, Quality Control, and Efficient Production practices.

Lead and execute process validation (PV) and test method validation (TMV) activities for the production line.

Develop and implement robust validation protocols and plans ensuring compliance with regulatory requirements and internal quality standards.

Analyses and interpret validation data, identify potential risks and improvement opportunities.

Prepare and submit validation reports for internal approvals.

Partner with the Production Managers to optimize production processes for efficiency and cost-effectiveness.

Oversee the calibration and maintenance of production equipment to ensure consistent output and product quality.

Partner with raw material and component suppliers, ensuring on-time delivery and consistent quality.

Provide technical support to the entire production team, including training, troubleshooting, and problem-solving.

Lead implementation of engineering change orders (ECOs) impacting the product, production line and supplier processes.

Act as Change/Solution Owner as it is described separately in Operation Org.

Manage and lead production technical issues and problem solving

Maintain and update Work Instructions, Forms and other supportive documentation

Write and implement Test Reports related to Manufacturing Engineering

Participate in GAMBA meetings

Skills:

Strong understanding of Quality Management Systems (QMS).

Excellent analytical and problem-solving skills, with a data-driven approach to continuous improvement.

Demonstrated leadership and communication skills, ability to motivate and collaborate effectively.

Education:

Bachelor’s degree in mechanical/Electronics Engineering or a related field required

Relevant Experience:

Minimum 2 years of experience in multidisciplinary system R&D/Production/Process Engineering

Advantage Experience:

Worked as a manufacturing Engineer

Proven expertise in process validation (PV) and test method validation (TMV) methodologies

Subordinate to:

Engineering Director

Languages:

• Fluent in English & Hebrew