NPI Engineer

HOYA LAMPHUN LTD. (Lamphun)

Lamphun

ลำพูน, ประเทศไทย

HOYA LAMPHUN LTD is manufactures of high quality glass disk for memory disk and the global leader in developing preloaded intraocular Lenses (IOLs) also produce the contact lenses, HOYA CORPORATION has established since 1941 at Hoya city ,Tokyo Japan. Now, HOYA CORPORATION has subsidiaries/branches over 35 countries around the world. HOYA LAMPHUN LTD. is the one of the branch which located in Northern Region Industrial Estate, Muang district, Lamphun province.

เกี่ยวกับตำแหน่งนี้

The NPI Engineer is responsible for leading New Process Improvement initiatives from concept to production, ensuring timely and budget-compliant execution while collaborating with various teams to enhance product quality and efficiency.

หน้าที่รับผิดชอบ

• New Process Improvement (NPI) initiatives from initial concept through to production release, ensuring all milestones are met on time and within budget.
• Coordinate with design engineering to review product designs for manufacturability and identify opportunities for cost reduction and process improvements.
• Develop and maintain NPI schedules, ensuring alignment with overall project timelines and business objectives.
• Collaborate with manufacturing teams to establish production processes, including equipment selection, tooling design, and assembly procedures.
• Conduct feasibility studies and risk assessments to anticipate and mitigate potential challenges.
• Implement quality control measures and performance metrics to monitor and optimize product quality.
• Act as a liaison between engineering, manufacturing and supply chain teams to resolve technical issues and ensure smooth production flow.
• Provide regular updates and reports to senior management on NPI progress, including status updates, key metrics, and risk assessments.
• Conduct equipment, process, and software validation.
• Issue Validation/Qualification protocols (IQ/OQ/PQ), coordinate the execution and ensure that all activities are executed according to the approved protocol.
• Document any deviation from the approved protocols (IQ/OQ/PQ).
• Consolidate all test data and ensure all requirements are completed prior to post-execution approval.
• Issue qualification reports (IQ/OQ/PQ).
• Develop or design machine jigs and tools to increase productivity and quality.

คุณสมบัติ

• Bachelor’s degree or above in Mechanical/Electrical/Industrial/Chemical engineering or related fields.
• 1-3 years of experience in process validation within a regulated industry (Medical Devices, Pharmaceutical).
• Understanding of quality standards and health & safety regulations (ISO13485, MDR, MDSAP etc.).
• Excellent in English communication, Reading and Writing.
• Highly motivated, organized and capable of managing priorities.
• Proficient in MS Office, Minitab, Six sigma, Good technical writing skills.
• Strong decision-making skills and a results-driven approach.