Mechanical Engineer

Haemonetics; Batu Kawan; On-site; MYR 67,000 - 112,000; Full time

Job summary

Haemonetics in Penang, Malaysia, is seeking a Mechanical Engineer to deliver project management and engineering solutions for medical devices and components at CM partner facilities in Penang, SEA and APAC. You will collaborate with cross-functional teams on NPI, problem solving, lifecycle and change control.

The role requires hands-on experience with CAD, GD&T, and manufacturing processes, with strong data-driven mindset and ability to drive continuous improvement across yield, quality and

Qualifications

• Bachelor's or master's degree in Mechanical Engineering or equivalent.
• 10 years of experience in manufacturing or engineering.
• Experience with Agile systems and related methodologies.
• Proficiency with Six Sigma and LEAN manufacturing principles.
• Proficiency in SolidWorks, GD, and tolerance stack-up analysis.
• Experience with die casting, injection molding, plastic extrusion, machining, or sheet metal.

Responsibilities

• Drive SCN/ECO/SPN deliverables from initial stage to closure and manufacturing implementation.
• Review/approve SCN/CAF/ECO/DR/JST/protocols/reports.
• Review/analyze/update 2D or 3D drawings/BOM/MI in Agile.
• Collaborate with R&D, Quality, Sourcing and contract manufacturers during NPI and mass production.
• Support manufacturing for yield, quality and materials availability challenges.
• Troubleshoot issues and report findings with a data-driven mindset.
• Monitor contract manufacturers' tooling and fixtures.
• Document activities with precision and carry out duties as assigned.

Skills

Agile methodologies

Six Sigma

LEAN manufacturing

SolidWorks

GD&T

Tolerance stack-up analysis

Statistical tools

Data analysis

Education

Bachelors/Masters degree in Mechanical Engineering

Tools

Die casting

Injection molding

Plastic extrusion

Machining

Sheet metal

Job description

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 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

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