Department: Operations
Location: APAC-Thailand
Description
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
Primary Responsibilities3. Production Readiness and Information Management5. Engineering Change Order (ECO) Execution7. Quarterly Production Planning8. Work Instructions Management
- 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 crossfunctional and crosssite meetings to align on priorities, schedules, and engineering directives.
- Provide structured feedback regarding production challenges, quality issues, and process deviations.
- 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.
- Ensure that all production documentationincluding drawings, BOMs, work instructions, and ECOsis 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 onfloor technical support to address realtime production issues.
- Management of CONQ, MRB, and FPY Metrics
- Monitor and report on Cost of NonQuality (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, rootcause analyses, and improvement actions.
- 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
- 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.
- 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.
- 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
Qualifications and Requirements
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 problemsolving skills.
Language and Communication
- Fluent English, both written and verbal.
- Strong communication skills with the ability to collaborate effectively across international teams and functions.
Applicant Privacy Policy
Review our
Applicant Privacy Policyfor additional information.
Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
