Mechanical Engineer

Haemonetics Interventional Technologies; Batu Kawan; On-site; MYR 60,000 - 120,000; Full time

Job summary

Haemonetics Interventional Technologies in Penang, Malaysia, is seeking a Mechanical Engineer to manage engineering solutions for medical devices across external CM partners. You will collaborate with R&D, Quality, and Sourcing during NPI, design transfer, V&V, and mass production stages to ensure yield, quality and material availability.

The role requires a Mechanical Engineering degree with 1–4 years in manufacturing or engineering, proficiency in statistical tools, Six Sigma and LEAN

Qualifications

• Degree in Mechanical Engineering (Bachelor's or Master’s).
• Experience in manufacturing, engineering, or equivalent.
• Familiarity with GMP, DOE, FAI, IQ/OQ/PQ protocols and reports.
• Knowledge of medical device manufacturing standards.

Responsibilities

• Drive SCN/CAF/ECO/DR&JST protocols from design to manufacturing closure.
• Collaborate with R&D, Quality, Sourcing and CM partners during NPI and mass production.
• Support yield, quality and materials availability across manufacturing stages.
• Document activities with data-driven precision and report progress.

Skills

Statistical tools

Six Sigma

LEAN manufacturing

NPI experience

Agile familiarity

Problem solving

Cross-functional collaboration

Education

Bachelor's/Master's Mechanical Engineering

Tools

SolidWorks

GD&T

Tolerance stack-up analysis

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

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.

• Bachelor's /master's degree of Mechanical Engineering or equivalent.
• Min 1-4 years working experiences in Manufacturing, Engineering or equivalent.
• 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

Throughout our history, we have earned a solid reputation for product innovation, technical expertise, and operational excellence. Today, our products, internal research and development, marketing partnerships, and product acquisitions reflect our unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals. We rely on our talented global workforce to help us achieve our mission of providing innovative medical devices that advance the safety, quality, and availability of the world's blood supply. To achieve our business goals and objectives, we are committed to attracting and retaining the best and brightest talent while offering a challenging, dynamic, and exciting work environment that offers professional growth and development.