Manufacturing Engineer Job at ZipRecruiter in Trenton

Job Description One Life Science is working with a Medical Device company that is a , innovative medical device manufacturer dedicated to developing life-changing technologies that improve patient outcomes. Position Overview We are seeking a Manufacturing Engineer with at least 4 years of experience in the medical device industry and a solid background working with machine shop operations . This role will support production scale-up, process optimization, and manufacturing readiness for new and existing Class I and II medical devices Key Responsibilities Support and improve existing manufacturing processes to ensure consistent product quality and compliance with FDA, ISO 13485, and other regulatory standards. Collaborate with R&D and Quality teams to transition new products into production (NPI). Design, document, and implement assembly and inspection procedures, fixtures, and jigs. Provide hands-on support in the machine shop for prototype fabrication, tooling, and maintenance. Drive root cause analysis and implement corrective actions for production issues using tools such as 5 Whys, FMEA, and fishbone diagrams. Monitor and report on manufacturing metrics (yield, downtime, scrap) and identify areas for cost and efficiency improvements. Train and support manufacturing technicians on new processes, tools, and safety procedures. Maintain accurate documentation (SOPs, work instructions, process validations, DMRs). Qualifications Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related field. Minimum 4 years of experience in a manufacturing engineering role within the medical device industry . Strong understanding of FDA QSR, ISO 13485 , and medical device documentation and validation practices. Hands-on experience with machine shop equipment (mills, lathes, grinders, CNCs) and the ability to read and interpret technical drawings and GD&T. Experience with lean manufacturing principles, Six Sigma tools, and process validation (IQ/OQ/PQ). Proficiency in CAD software (SolidWorks ). Excellent communication skills and the ability to work cross-functionally in a fast-paced environment. Qualifications Experience supporting electromechanical systems. Certification in Six Sigma or Lean Manufacturing. ERP/MRP experience (SAP, Oracle, or equivalent). #J-18808-Ljbffr