Sr. Production Engineer

About the Role

Department: Operations
Location: APAC-Thailand (Chonburi, Thailand)
Employment type: Full-time, Onsite

The Sr. Production Engineer is responsible for supporting the operational and engineering activities associated with the FBN product line, acting as the primary liaison between the Israeli engineering team and the local production organization to ensure technical, quality, and operational requirements are communicated, implemented, and maintained.

Responsibilities

• Interface with the Israeli engineering team as the central point of contact; ensure timely and accurate transfer of technical information, participate in cross‑functional/cross‑site meetings, and provide structured feedback on production challenges and process deviations.
• Maintain full quality oversight for the FBN wand across all production stages: monitor and analyze quality indicators, ensure adherence to product specifications and regulatory standards, coordinate with Quality Assurance on nonconformities and corrective actions, and support internal/external audits.
• Manage production readiness and information: ensure production documentation (drawings, BOMs, work instructions, ECOs) is complete, accurate, current, and accessible; provide on‑floor technical support and resolve documentation or specification gaps.
• Manage CONQ, MRB, and FPY metrics: monitor and report Cost of Non‑Quality, lead Material Review Board activities (defect assessment, disposition), track First Pass Yield, and prepare structured performance and root‑cause analysis reports.
• Execute Engineering Change Orders (ECOs): review ECOs for completeness and feasibility, coordinate implementation including updates to documentation, tooling, and procedures, communicate changes to production personnel, and track ECO progress.
• Oversee jigs and fixtures management: ensure maintenance, calibration, repairs/modifications, revision control, and collaborate with engineering on tooling design/improvements.
• Develop quarterly production plans in coordination with planning, supply chain, and engineering; assess capacity, resource requirements and material availability; identify risks and propose mitigation; monitor execution and adjust plans as needed.
• Review, update, and maintain work instructions (WIs); ensure clarity, accessibility, conduct training for production personnel, and maintain documentation control to meet internal and regulatory expectations.

Qualifications

• Education: Bachelor of Science (B.Sc.) in Electromechanical Engineering or a related technical discipline.
• Experience: Minimum 5 years in the medical device industry, preferably in manufacturing, production engineering, NPI, or quality roles; experience in regulated environments (e.g., ISO 13485, FDA, MDR) is strongly preferred.
• Technical competencies: strong understanding of engineering documentation, ECO processes, production workflows, quality metrics (CONQ, MRB, FPY), ability to interpret engineering drawings/specifications, and familiarity with jigs/fixtures and production tooling maintenance; strong analytical, organizational, and problem‑solving skills.
• Language & communication: Fluent English (written and verbal) with strong cross‑functional and international collaboration skills.

Additional Information

This position is based in Chonburi, Thailand. Align Technology is an equal opportunity employer.