Job Description:

FirstPro is now accepting resumes for a Senior Manufacturing Engineer position based in Waltham, MA. This role will focus on providing support for manufacturing operations focusing around Test Strip manufacturing. You will work on leading development, designing and validating existing equipment and processes. This is a permanent, direct-hire role that can offer benefits.ResponsibilitiesWriting and updating the support documentation (APs, TPs, and OIs) for the process, developing, writing and performing IQ, OQ and VQs used in the manufacturing of Test StripsPerforming engineering studies and analyses on existing manufacturing processes to improve process reliability, problem solving, or improving product quality or cost.Designing or purchasing tooling and equipmentUsing appropriate statistical techniques to develop and complete process capability studiesActively participating in other team activities to help ensure total team successTaking an active role in learning for self and others to further company objectivesParticipation in design reviews on new products during development phase.Manage technical resources consisting of engineerstechnicians in the transfer of new processes and assemblies to manufacturing as well as providing cost estimates, creating work breakdown structures, creatingmaintaining project schedules, providing project status reports, presentations of concernsaccomplishments to team and upper management.Manage the various functions of projects for proper implementation that meets all regulatory guidelines including the creation and performance of Installation, Operational & Performance Qualifications, Process Validations and Failure Mode Effects Analysis (FMEA).Design fixtures and necessary tooling for processes or modifications to equipment as needed. This includes researching and finalizing specifications for capital equipment as well as supplier quote comparison and ROI analysis.Create new manufacturing documentation and updatingenhancing existing documentation which conform to Quality System Regulations (QSR's) ISO Standards.Train and or oversee the training of employees on new products, equipment, and processes.RequirementsB.S in Mechanical EngineeringBiomedicalElectromechanical Engineering with 5-10 years of experience in the Biomedical or High Volume manufacturing field.Must have experience maintaining and troubleshooting complex high volume automated manufacturing equipment.Experience with vision inspection systems, electronics, pneumatics and machine control systems a plus.Must be proficient with Microsoft Office, (Solidworks andor AutoCAD programs.Must have strong written and oral communication skills.Knowledge of FDA QSR's and ISO regulations is helpful.