The Principal R&D Process Engineer manages a wide variety of technical tasks and projects in the development of new products and manufacturing processes. This individual will be a technical leader within the R&D team and a key member of the medical device product development teams.
· Contribute directly to the development of new product concepts, processes, and techniques to ensure that products meet customer’s needs and are high quality and low cost.
· Serve as a technical interface within Alere between the Manufacturing and Materials, R&D, Quality, Regulatory, and Marketing organizations.
· Manage/hands-on design and development of new products and processes as well as product changes and enhancements. S/he will demonstrate knowledge to chemistry, plastics, molded and machine part design as per program requirements.
· Work closely with external partners to transfer new materials and mechanical products to manufacturing. This person will plan, schedule and complete the DFM projects as per the program timelines.
· Will possess a working application/knowledge of medical device regulatory requirements and standards.
· Write phase review updates and reports for design verification/process validation, complete testing, and transfer to manufacturing. Including Manufacturing Process Instruction (MPI), Lot History Record (LHR), Bill of Material (BOM) and other production documentation.
· Lead and directly participate in the design and testing of manufacturing fixtures and equipment.
· Directs DFM activities within the R&D program team.
· Lead and be responsible for the design transfer into operations
Desired Skills and Experience
Bachelor’s degree in chemistry, manufacturing engineering, mechanical engineering or industrial engineering preferred.