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Job Details
Job Summary
Mechanical Engineer is responsible for providing project management and engineering solution for medical products both equipment and disposables which are primarily located at external contract manufacturing (CM) partner’s facilities at Penang, SEA and APAC. The engineer will be collaborating with cross-functional teams and stakeholders (both internal and external) for NPI, problems solving, lifecycle & change control management.
Responsibilities:
Drive SCN/ECO/SPN deliverables from Initial stage to closure & manufacturing implementation.
Generate, review and reject/approve SCN/CAF/ECO/DR/JST/protocols/reports.
Review/analyze/update 2D or 3D mechanical drawings/BOM/MI in Agile.
Work closely with Haemonetics R&D, Quality, Sourcing and contract manufacturers during NPI, design transfer, V&V and mass production stage.
As primary engineering focal to support manufacturing for yield, quality and materials availability challenges.
Troubleshoot issues, investigating independently/with a team, leveraging expertise across functions, with sensitivity to deadlines and balances priorities.
Monitor contract manufacturer and sub-tier suppliers tooling and fixtures owned by Haemonetics.
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 Engineering or equivalent.
Min 1-4 years working experiences in Manufacturing, 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.
Proficiency in SolidWorks, GD&T, tolerance stack-up analysis.
Experience in the development and/or production of die casting, injection molding, plastic extrusion, machining, sheet metal.
Comprehensive understanding of medical device manufacturing standards, including but not limited to:
Good Manufacturing Practice (GMP)
Process Validation and Verification
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
EEO Policy Statement
