Manufacturing Product Leader

Position's Scope:

• The Manufacturing Product Leader 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 all 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.
      • Analyse and interpret validation data, identify potential risks and improvement opportunities.
      • Prepare and submit validation reports for regulatory submissions and internal approvals.
      • Partner with the Production Managers to optimize production processes for efficiency and cost-effectiveness.
      • Identify and implement process improvements through Lean manufacturing principles, automation, and new technologies.
      • Analyze production data to identify trends, bottlenecks, and root causes of defects.
      • Develop and implement reporting systems for tracking production output, quality metrics, and performance indicators.
      • Oversee the calibration and maintenance of production equipment to ensure consistent output and product quality.
      • Manage relationships with raw material and component suppliers, ensuring on-time delivery and consistent quality.
      • Conduct Engineering audits and inspections of supplier facilities and processes to meet our requirements.
      • Provide technical support to the entire production team, including training, troubleshooting, and problem-solving.
      • Identify and evaluate opportunities for automation and integration of new production tools.
      • Lead design and implementation of engineering change orders (ECOs) impacting the production line and supplier processes.
      • Maintain a deep understanding of regulatory requirements and medical product quality standards.
        • • Act as Change/Solution Owner as it is described separately in Operation Org.
          • Lead VA/VE (Value Analysis and Value Engineering) Activities
          • Maintain real and updated COGS
            
            • Measurements
            • Analytics
            • Optimization
            • Finance
            • Support Planning related activities to achieve OTIF and OTD
            • 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
            • Lead and motivate the production team members, fostering a culture of continuous
              improvement and quality.
            • Proactively communicate production status, challenges, and solutions to
              cross-functional teams
            • work effectively with the Manufacturing Engineering Director, Supply Chain Director, and Production Director to achieve operational goals.

Skills:

1. • Strong understanding of Quality Management Systems (QMS) and regulatory requirements for medical devices.
   • 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 Engineering or a related field required.

Relevant Experience:

• •  Minimum 4 years of experience in manufacturing of medical devices or similar products.
  • Proven expertise in process validation (PV) and test method validation (TMV) methodologies.

Advantage Experience:

Worked as a manufacturing Engineer

Subordinate to:

VP Operations

Languages:

Fluent in English & Hebrew

Comments:

See Appendix #1 for detailed R&Rs

To apply, send your resume to hr@arineta.com