Sr Mfg Engineer – Direct – Lawrence, MAProvide technical expertise and support related to existing and new manufacturing processes. Introducing new products and processes into production, including leading Process Development and Process Validation activities related to Disposable and Hardware production. Creation of Production Documentation including Manufacturing, Inspection and Test Instructions and submit for approval using document change order procedures. Creation of Assembly and Component Drawings Selection, design, installation and maintenance of Equipment, Tooling, and fixtures used in Production. Identify opportunities to streamline production through process improvements, test improvements, and product design changes. Identify and resolve technical and quality related issues including participation in MRB, customer complaint investigations, and CAPA related activities. Support continuous improvement project initiatives focused on improving product quality and reducing cost. Support Quality with activities related to quality and inspection procedures, incoming inspection methods, measurement system analysis (MSA), first article inspection (FAI), and gage repeatability and reproducibility (GR&R) activities.6-10 years of experience working in an FDA/ISO regulated Medical Device/Medical Equipment IndustryBS in Engineering plus Must have experience developing and executing Process Validation plans Must have experience in the design and development of production fixtures and tooling. Ability to create 3D models and drawings working with Solidworks, and/or Pro Engineer Experience with sustaining activities and product design activities a plus. Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus. Experience using Minitab or similar statistical evaluation software/tools.
