Sr. Electromechanical Manufacturing Engineer (FDA)

Kforce has a client in need of a Senior Electromechanical Manufacturing Engineer (FDA). Responsibilities: * Create and implement new manufacturing processes for medical devices * Collaborate with global suppliers to define manufacturing processes, equipment, and tools/fixtures to ensure quality products * Perform characterization studies, Design of Experiments (DoE), and validation/verification of processes and inspection methods (IQ, OQ, PQ) * Develop manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents * Lead teams of engineers and technicians on manufacturing activities * Innovate, design, and develop processes, procedures, tooling, and automation * Train and provide direction to manufacturing personnel * Drive functional excellence initiatives for product/process and technical development * Monitor KPIs/metrics and implement improvement projects as needed * Assist in developing department budgets, schedules, and resource plans * Perform other duties as assigned* Bachelor's degree in Engineering (Mechanical, Electrical, or related field) * 6+ years as a process/manufacturing engineer in a regulated environment; FDA experience in pharma or medical device industry required * Expertise in Design for Manufacturing, Assembly, and Test (DFMAT), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer, FMEA, and problem-solving methodologies * Strong understanding of Quality Management Systems, design controls, and product development processes * Solid knowledge of FDA regulations, guidelines, and policies for medical devices * Experience with electromechanical systems and durable materials required * Proficiency with CAD software (SolidWorks preferred) * Excellent verbal/written communication and organizational skills * Six Sigma Certification preferred