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 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 Haemonetics 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 Haemonetics 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. Comply with the ISO14001 Environmental Management System policy, SOP and requirements Continuous support to the development and implementation of program to achieve and maintain the ISO 14001 environmental management system. Job Requirement:- 10+ years of experience managing cross functional project in regulated environment Bachelor\'s degree in Engineering Mechanical/Plastic discipline or equivalent Highly proficient with computer program e.g. MS Excel, Power Point, Project and CAD software Experience with six Sigma and Lean Manufacturing methodologies Proficiency with practical knowledge in ISO 13485, FDA 21 CFR Part 820, EU Medical Device Directive requirements, Medical Device Single Audit Program (MDSAP), EU Medical Device Regulation (EU MDR 2017/745), Good Distribution Practice for Medical Devices (GDPMD). Experience in manufacturing process control and process validation requirements, including statistical tools Preferred: Experience with in Medical Device, pharmaceutical industrial. EEO Policy Statement

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