Senior Engineer, Disposables R&d

Pulau Pinang, Malaysia

Job Description


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.

Job 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 disposables are tested in accordance with Good Laboratory Practices and Test Methods are optimized for quality, reliability, and Design For Manufacturing Quality.
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.
  • Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organization\xe2\x80\x99s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Requirements:
  • Bachelor\'s Degree of Engineering including mechanical, plastics, industrial, or other engineering discipline; Master\'s Degree is preferred.
  • 5 years of experience in managing cross-functional projects in regulated environment
  • Quality engineering experience is good to have.
  • Six Sigma, Black Belt Certification is good to have.
  • Project Management certification is good to have.

PersolKelly

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Job Detail

  • Job Id
    JD905899
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    6000 - 12000 per month
  • Employment Status
    Permanent
  • Job Location
    Pulau Pinang, Malaysia
  • Education
    Not mentioned