staff manufacturing engineer.

Key Responsibilities:Partner with R&D to ensure manufacturability, process repeatability, and seamless design transfer.Provide DFM, DFA, DFR, and DFS recommendations during component and assembly design reviews.Develop and execute process validation protocols, including verification, optimization, and validation reports.Own and maintain process documentation such as Manufacturing Instructions, PFMEA, Control Plans, and Standard Work Procedures.Lead root cause analysis and corrective action implementation for process and product failures.Drive NPI projects by managing schedules, cross-functional collaboration, and design transfer deliverables.Implement advanced manufacturing technologies, automation, and best practices for improved efficiency.Design and qualify custom fixtures to support production processes.Support capacity planning, production workflows, and floor layouts to optimize manufacturing operations.Train and mentor technicians and production staff on new processes and best practices.Ensure compliance with FDA QSR, ISO 13485, and other regulatory standards.Up to 20% domestic and international travel required.Qualifications:BS in Engineering (Mechanical, Electrical, or related field); MS preferred.5+ years (BS) or 3+ years (MS) of experience in NPI manufacturing engineering within a regulated industry.Expertise in electromechanical assembly processes and capital equipment manufacturing.Strong background in process validation, root cause analysis, and Lean/Six Sigma methodologies.Experience with BOM management, change control, and ERP systems (Salesforce, QAD preferred).Working knowledge of ISO 9000, FDA QSR, and cGMP requirements.Proficiency in CAD software (SolidWorks preferred) and Microsoft Office.

4-7 years

.

Staff Manufacturing EngineerOverview:A leading surgical robotics company is seeking a Staff Manufacturing Engineer to enhance manufacturing operations. This role focuses on managing internal and contract manufacturing processes, supporting R&D for new process implementation, and driving quality, delivery, and cost improvements.Key Responsibilities:Collaborate with R&D to ensure design choices support manufacturability and process repeatability.Provide DFM, DFA, DFR, and DFS recommendations for component and assembly design.Lead manufacturing process validation, optimization, and documentation.Develop and maintain process documentation, including Manufacturing Instructions, PFMEA, and Control Plans.Introduce and implement advanced manufacturing technologies, equipment, and automation.Design and oversee fabrication of custom fixtures.Support production planning, capacity assessment, and workflow optimization.Conduct root cause analysis and corrective action implementation for product and process failures.Manage NPI projects, schedules, and cross-functional collaboration.Provide training and technical guidance to operators and technicians.Ensure compliance with quality and regulatory standards.Up to 20% domestic and international travel required.Qualifications:BS in Mechanical, Electrical, or related Engineering field (MS preferred).6+ years of experience in manufacturing engineering, preferably in medical device capital equipment.Expertise in electromechanical assembly processes and root cause analysis.Experience with BOM creation, change management, and software releases.Familiarity with Lean, Six Sigma, and structured design processes (ISO 9000, FDA QSR).Proficiency in CAD (SolidWorks preferred) and Microsoft Office.Work Environment:Exposure to engineering labs, machine shops, and manufacturing areas.Moderate noise levels; use of protective equipment as needed.Occasional lifting of up to 50 lbs.This position offers the opportunity to drive innovation and efficiency in a dynamic, high-tech manufacturing environment.

Bachelors