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.

• 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.

• 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