Job Description

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\'s 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\'s to ensure the TMV\'s are validated. Develop fixtures, TMV\'s 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\'s 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 ofexperience in managing cross-functional projects in regulated environment Quality engineering experience is good to have. Six Sigma, Black Belt Certificationis good to have. Project Management certificationis good to have.

Monster