Sr. Production Engineer

The Sr. Production Engineer is responsible for supporting the operational and engineering activities associated with the FBN product line. This position serves as the primary liaison between the Israeli engineering team and the local production organization, ensuring that all technical, quality, and operational requirements are communicated, implemented, and maintained. The role includes oversight of production readiness, quality performance, engineering change management, tooling maintenance, and documentation control, with a strong emphasis on compliance, accuracy, and continuous improvement.

This position is based in Chonburi, Thailand.

Key Responsibilities

1. Interface with the Israeli Engineering Team

• Serve as the central point of contact for all communication with the Israeli engineering and operations teams.

• Ensure timely and accurate transfer of technical information, updates, and production requirements.

• Participate in cross‑functional and cross‑site meetings to align on priorities, schedules, and engineering directives.

• Provide structured feedback regarding production challenges, quality issues, and process deviations.

2. Quality Oversight for the FBN Wand

• Maintain full responsibility for the quality performance of the FBN wand throughout all stages of production.

• Monitor and analyze quality indicators, ensuring adherence to product specifications and regulatory standards.

• Coordinate with Quality Assurance to investigate nonconformities, implement corrective actions, and prevent recurrence.

• Support internal and external audits related to the FBN product line.

3. Production Readiness and Information Management

• Ensure that all production documentation—including drawings, BOMs, work instructions, and ECOs—is complete, accurate, and current.

• Confirm that the production team receives all necessary technical information to support uninterrupted manufacturing operations.

• Coordinate with engineering to resolve documentation gaps, technical discrepancies, or specification ambiguities.

• Provide on‑floor technical support to address real‑time production issues.

4. Management of CONQ, MRB, and FPY Metrics

• Monitor and report on Cost of Non‑Quality (CONQ), identifying trends and areas requiring improvement.

• Lead Material Review Board (MRB) activities, including defect assessment, disposition decisions, and documentation.

• Track First Pass Yield (FPY) performance and drive initiatives to improve yield and reduce rework.

• Prepare structured reports summarizing performance metrics, root‑cause analyses, and improvement actions.

5. Engineering Change Order (ECO) Execution

• Review Engineering Change Orders for completeness, feasibility, and impact on production processes.

• Coordinate the implementation of ECOs, ensuring that all affected documentation, tooling, and procedures are updated accordingly.

• Communicate changes to production personnel and verify proper execution on the manufacturing floor.

• Track ECO progress to ensure timely and compliant implementation

6. Jigs and Fixtures Management

• Oversee the maintenance, calibration, and operational readiness of all jigs and fixtures used in the FBN production line.

• Coordinate repairs, modifications, and replacements as required.

• Collaborate with engineering to support the design and improvement of production tooling.

• Maintain accurate records and revision control for all tooling assets.

7. Quarterly Production Planning

• Develop quarterly production plans in coordination with planning, supply chain, and engineering functions.

• Assess capacity, resource requirements, and material availability to support production targets.

• Identify risks or constraints and propose mitigation strategies.

• Monitor plan execution and adjust as necessary to meet delivery commitments.

8. Work Instructions Management

• Review, update, and maintain Work Instructions (WIs) to ensure alignment with current engineering requirements and best practices.

• Ensure that WIs are clearly written, properly formatted, and accessible to production personnel.

• Conduct training sessions to ensure proper understanding and implementation of updated instructions.

• Maintain documentation control and ensure compliance with internal standards and regulatory expectations.

Skills, Knowledge & Expertise

Education

• Bachelor of Science (B.Sc.) in Electromechanical Engineering or a related technical discipline.

Professional Experience

• Minimum of 5 years of experience in the medical device industry, preferably in manufacturing, production engineering, NPI, or quality roles.

• Experience working within regulated environments (e.g., ISO 13485, FDA, MDR) is strongly preferred.

• Background in electromechanical assemblies or precision manufacturing is an advantage.

Technical Competencies

• Strong understanding of engineering documentation, ECO processes, and production workflows.

• Experience with quality metrics, including CONQ, MRB, and FPY.

• Ability to interpret engineering drawings, specifications, and technical documentation.

• Familiarity with jigs, fixtures, and production tooling maintenance.

• Strong analytical, organizational, and problem‑solving skills.

Language and Communication

• Fluent English, both written and verbal.

• Strong communication skills with the ability to collaborate effectively across international teams and functions.