Manufacturing Engineer

9 hours ago

Batu Kawan, Penang, Malaysia Haemonetics Full time 60,000 - 120,000 per year

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job DetailsJob SummaryManufacturing Engineer is responsible for providing project management and engineering support for medical products (both Liquid Solutions and Disposables) which are primarily located at external contract manufacturing (CM) partner's facilities at SEA/APAC/Europe. The engineer will be collaborating with cross-functional teams and stakeholders, both internal and external to Haemonetics, and providing engineering solutions to solve manufacturing process, component availability & change control management.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 2-4 years working experiences in Manufacturing, Quality, Engineering or equivalent. .
  • 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

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