Senior Engineer, Disposables R&D

• 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.

• 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.

Haemonetics