Talent.com
Tawaran kerja ini tidak tersedia di negara anda.
Manufacturing Engineer

Manufacturing Engineer

Haemonetics Malaysia Sdn BhdButterworth, Pulau Pinang, Malaysia
11 jam yang lalu
Penerangan pekerjaan

Responsibilities :

  • Drive SCN / ECO deliverables from Initial stage to closure & manufacturing implementation.
  • Generate, review and reject or approve SCN / CAF / ECO / test protocols / reports.
  • Generate Agile ECO SPN (Specification Package Notification) to external contract manufacturers.
  • Perform OH stocks, Production Impact date, Last Time Buy analysis for EOL components.
  • Perform presentation to cross region, cross functional teams & route DR for approvals in Agile.
  • Review / update manufacturing working instruction / BOM in Agile system.
  • Work closely with Haemonetics R&D, Quality, Sourcing, RA and contract manufacturers to solve or de-risk manufacturing day to day challenges.
  • Able to document and report activities with appropriate amount of precision with data driven mentality.
  • Carryout any other duties and responsibilities as assigned by supervisor.

Requirements :

  • Bachelor's / master's degree of Mechanical, Biomedical, Chemical Engineering or equivalent.
  • Min 2-3 years working experiences in Manufacturing, Quality, Engineering or equivalent. Fresh Graduates are encouraged to apply.
  • Candidates who demonstrated experience and knowledge in one or more of the following areas will be given strong consideration :
  • Familiarity with the Agile system and related methodologies.
  • Proficiency in basic statistical tools, as well as experience with Six Sigma and LEAN manufacturing principles.
  • Experience in the development and / or production of Class I, II, or III medical devices.
  • Comprehensive understanding of medical device manufacturing standards, including but not limited to :
  • Good Manufacturing Practice (GMP)
  • Process Validation and Verification
  • Process Failure Mode and Effects Analysis (PFMEA)
  • Risk Management and development of Control Plans
  • Gauge Repeatability and Reproducibility (GR&R)
  • Design of Experiments (DOE)
  • First Article Inspection (FAI)
  • Preparation and execution of IQ / OQ / PQ protocols and reports
  • Statistical Process Control (SPC) and Process Capability Analysis
  • Application of Six Sigma methodologies for problem-solving
    • Buat amaran kerja untuk carian ini

    Manufacturing Engineer • Butterworth, Pulau Pinang, Malaysia