Senior Manufacturing Engineer

1 day ago

Kulim, Kedah, Malaysia AMS Full time

The Senior Manufacturing Engineer will be responsible for supporting the sustaining manufacturing line to a high scale production. You will support processes as required to provide daily operations support to the manufacturing floor including inputs to monitoring and control to maintain robust processes. This role will interact with different areas in the organization including quality, R&D, Regulatory, Operations, Marketing, Supply Management etc.

Provide support to the manufacturing processes ensuring output. Support day-to-day activities as manufacturing needs to ensure optimization of manufacturing and/or investigations as needed.

Responsibilities:

·       Oversee shift operations to maintain continuous production, resolving documentation, material, and equipment issues promptly.

·       Act as liaison between production and engineering management, providing updates and escalating issues as needed.

·       Author and maintain production documents, templates, reports, specifications, and equipment protocols; conduct equipment qualifications and validations.

·       Investigate and resolve equipment, process, and product non-conformances through root cause analysis and corrective actions.

·       Develop innovative solutions to recurring production challenges and collaborate with production personnel on improvement initiatives.

·       Provide training and support to production teams to enhance process understanding and efficiency.

·       Partner with New Product Introduction/Transfer teams to execute calibration, process validation (IQ/OQ/PQ), and Test Method Validation (TMV) protocols.

·       Design and optimize manufacturing processes, layouts, and workflows for assemblies, equipment installation, and material handling.

·       Ensure compliance with regulatory requirements and incorporate inspection and test requirements into production plans.

·       Monitor and improve machinery performance, initiating corrective actions to maintain product quality.

·       Apply statistical process control techniques and provide guidance on design concepts to maximize equipment utilization and manufacturing efficiency.

Basic Qualifications:

·       Bachelor's degree in engineering or sciences with 4+ years of experience or a master's degree in engineering or sciences with 2+ years of experience.

Desired Skills & Experience:

·       Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.

·       Knowledge of GD&T & experience in interpreting mechanical drawings.

·       Strong communication skills, both oral and written.

·       Experience with risk management, including but not limited to Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk management tools.

·       Experience in FDA 21 CFR Part 820 Medical Device Manufacturing, or ISO 13485 is preferred.

·       Knowledge of Engineering Change management processes and PLM tools such as Agile, PTC Windchill is preferred. (Any PLM)

·       Good interpersonal skills and ability to independently handle projects with minimal supervision.

·       Ability to manage/interact with suppliers and contract manufacturers

·       Medical device product development and/or manufacturing experience and a strong understanding of FDA, ICH and IEC standards

  • Experience across the entire product lifecycle.

  • Manufacturing Engineer

    1 week ago

    Kulim, Kedah, Malaysia CKD Malaysia Sdn Bhd Full time

    Job Title: Manufacturing Engineer (Front End/Back End)Company: CKD Malaysia Sdn. Bhd.Location: Kulim, KedahJob Type: Full-timeAbout the RoleWe are seeking a skilled Manufacturing Engineer (Front End) to support and optimize our manufacturing processes related to UHP/HP (Ultra High Purity / High Purity) tubing. This role focuses on front-end processes such as...

  • Lead Engineer, Manufacturing Process

    1 week ago

    Kulim, Kedah, Malaysia Celestica International LP Full time

    Req ID: Remote Position: NoRegion: Asia Country: Malaysia State/Province: Kedah City:  KulimGeneral OverviewFunctional Area:  Engineering Career Stream:   Process Engineering Manufacturing    SAP Short Name:  MG1-ENG-PRMJob Level:  Level 09IC/MGR: Senior Lead Engineer, Manufacturing Process     Direct/Indirect Indicator:  IndirectSummaryThe...

  • Manufacturing Engineering Engineers

    1 week ago

    Kulim, Kedah, Malaysia First Solar Malaysia Full time

    Basic Job Functions:Conceives, develops, and evaluates plans and criteria for the completion of process improvement projects and programs in a cost-efficient manner.Education/Experience:Bachelors Degree in an engineering discipline or Physical Science Field or the equivalent. Preferably: Mechanical, Mechatronics, Materials, Manufacturing Engineering. 3-5...

  • Senior Supervisor, Manufacturing

    2 weeks ago

    Kulim, Kedah, Malaysia Entegris Full time

    Job Title:Senior Supervisor, ManufacturingJob Description:The Role: Senior Supervisor, ManufacturingThe Senior Supervisor, Manufacturing is responsible for overseeing assembly line operations, managing a team of Line Leaders and Operators. This role ensures smooth production flow, supervises cleanroom activities, and drives operational efficiency through...

  • Mgr, Manufacturing Integrator

    1 week ago

    Kulim, Kedah, Malaysia LAM RESEARCH INTERNATIONAL SDN. BHD. Full time

    As a Manufacturing Integrator (MI) Manager, you will lead a team of integrators and drive cross-functional collaboration to ensure seamless execution of manufacturing delivery plans. You will be responsible for aligning strategic objectives with shop floor operations, optimizing production flow, and resolving systemic issues to support on-time delivery and...

  • Senior Molding Engineer

    1 day ago

    Kulim, Kedah, Malaysia AMS Full time

    The Senior Molding Engineer is responsible for establishing robust injection molding processes and providing ongoing technical support to ensure continuous, high-quality production. This role focuses on process setup, troubleshooting, and optimization while driving efficiency and compliance with regulatory standards.Responsibilities:·       Set up and...

  • Lead Engineer, Manufacturing Process 1

    2 weeks ago

    Kulim, Kedah, Malaysia Celestica Full time 60,000 - 120,000 per year

    Req ID: 129583Remote Position: NoRegion: AsiaCountry: MalaysiaState/Province: KedahCity: KulimGeneral OverviewFunctional Area:EngineeringCareer Stream:Process Engineering ManufacturingSAP Short Name:LEN-ENG-PRMJob Level:Level 08IC/MGR:Individual ContributorDirect/Indirect Indicator:IndirectSummaryThe Lead Engineer, Manufacturing Process is responsible for...

  • Epitaxy Process Engineering Senior Manager

    2 weeks ago

    Kulim, Kedah, Malaysia ams OSRAM Full time 200,000 - 250,000 per year

    The ams OSRAM Opto Semiconductors business offers high-performance opto semiconductor components and in-depth support for state-of-the-art system solutions based on innovative semiconductor light sources. The Business Unit can look back on almost fifty years of production and development expertise.Leadership role in overseeing MOVPE nitride epitaxy,...

  • Senior Supplier Quality Engineer

    1 day ago

    Kulim, Kedah, Malaysia AMS Full time

    Responsibilities:· Ensure that suppliers deliver quality parts, materials, and services.· Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.· Monitors parts from acquisition through the manufacturing cycle and communicate and resolves supplier-related...

  • Manufacturing Technician

    1 week ago

    Kulim, Kedah, Malaysia Intel Corporation Full time

    Job Details:Job Description: This role requires regular onsite presence to fulfill essential job responsibilities and ready to work in shift. Performs assigned product manufacturing and assembly tasks in the production process, ensuring that the finished products match the industry standards and customer specifications. Also supports developing, building...