Location: Raynham,MA, USA
JOB DESCRIPTION
Insight Global is hiring for a Mechanical Engineer in Massachusetts to support their client. They will be supporting a large-scale foundry capacity expansion project within the Raynham, MA, manufacturing facility. This position is based on-site as the engineer will be required to interface with manufacturing equipment, medical device products, and cross-functional partners. The daily tasks in scope of this role include but are not limited to the following: * Developing, writing, reviewing, maintaining and revising manufacturing documentation, i.e. Process Work Instructions, Manufacturing Specifications, Inspection Procedures to support product Manufacturing * Supporting the development and execution of manufacturing equipment qualifications (URS/FAT/SAT/IQ) * Supporting the development and execution of process validations (OQ/PQ/PV) * Developing, writing, and reviewing various validation deliverables, i.e. CSV-E, Engineering Studies, etc. * Partnering with cross functional partners to ensure sound validation strategy and smooth transitions to production go-live * Ensuring adequate documentation where necessary within the Quality System In order to successfully deliver on the above the incumbent will apply comprehensive and diverse knowledge of Engineering principles and practices as well as problem solving, risk management skills, and communication skills. *This candidate will also be responsible for equipment design, implementation, and validation
REQUIRED SKILLS AND EXPERIENCE
A minimum of a bachelor's degree in engineering, Science, or related technical field. At least 3 years of experience with Validation writing documentation and executing. At least 3 years of experience as a Mechanical Engineer, Validation Engineer, or Manufacturing Engineer Knowledge of statistical data analysis tools. Program experience- Microsoft word, PowerPoint, word, & excel.
NICE TO HAVE SKILLS AND EXPERIENCE
Experience in manufacturing: metal casting processes, CNC machining processes, metal finishing processes, Gage R&R CNC equipment, plastic or wax injection, laser processing or production automation Experience in a Medical Device work environment. Experience working in both an FDA and European regulatory environment in manufacturing/operations. Foundry experience Robotics experience- being familiar Knowledge of IQ, OQ, PQ within a manufacturing environment