Job Description

Company Background: A US-based healthcare company that specialized in blood management. This position will be based in Penang Malaysia which known as the APAC distribution hub cum the first manufacturing plant in Asia, commenced operation since 2015. Role Summary: Responsible to lead the disposables R&D test laboratory. The Senior Engineer will design fixtures, specify appropriate equipment and develop Test Method Validations (TMV) for disposable products. Responsible for translating TMVs into Standard Operating Procedures, which may be transferred to Manufacturing sites for Quality Assurance, routine testing. This Senior Engineering role maintains a local laboratory to ensure company\xe2\x80\x99 disposables are tested in accordance with Good Laboratory Practices and Test Methods are optimized for quality, reliability, and Design For Manufacturing Quality Job Responsibilities:

• Act as project manager for the introduction and/or integration of new disposables Test Methods and new equipment needs in an R&D setting. These TMV\xe2\x80\x99s may eventually be transferred into the Manufacturing organization.
• Constantly research for new equipment, testing processes and design transfer techniques, which can be utilized to improve Design Verification testing and Manufacturing Inspections.
• Develop new techniques and fixtures for product testing with supporting GR&R\xe2\x80\x99s to ensure the TMV\xe2\x80\x99s are validated.
• Develop fixtures, TMV\xe2\x80\x99s and equipment that meets Design Control requirements, that then can be transferred to Manufacturing locations for routine use.
• Ensure projects are completed on time, and within budget. Provide regular updates and project summaries to company R&D and Project Management.
• Ensure augmented technician support is trained on the study & equipment and assigned to support the testing priorities of project teams.
• Manage projects in compliance with company SOPs by employing techniques such as project plans, product specifications, required documentation, test protocols and test reports.
• Provide laboratory assistance for Scientific Services and Disposables initiatives.
• Provide technical leadership and consulting services to worldwide plasma disposables manufacturing operations.
• Responsible for the design transfer of measurement systems for monitoring key aspects of the technology transfer process.

Job Requirements:

• Bachelor\'s Degree Engineering including mechanical, plastics, industrial, or other engineering discipline (Required); Master\'s Degree Advanced degree (Preferred)
• 5 years Experience managing cross-functional projects in regulated environments
• Quality engineering experience is preferred
• Six Sigma, Black Belt Certification and Project Management certification is preferred

Job Types: Full-time, Permanent Salary: RM5,000.00 - RM12,000.00 per month Benefits:

• Cell phone reimbursement
• Free parking
• Health insurance

Schedule:

• Fixed shift
• Monday to Friday