Manufacturing Engineer 3
Core
Apply manufacturing strategies to optimize existing production systems or design and implement new systems to increase efficiency, competitiveness, and quality.
Role type
Manufacturing Engineer
Builds
Medical dialysis products (cyclers, cartridges, dialysate) and related manufacturing infrastructure
Domain
Medical device manufacturing / Dialysis equipment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing process engineering, Process validation, CAPEX project management, Root cause analysis, Statistical analysis, Cost-benefit analysis, New process implementation, Equipment evaluation and installation, Production line balancing, Product transfer evaluation, Layout design, BOM management, SOP development, Lean Manufacturing, Six Sigma, GMP/QSR/FDA compliance
Preferred skills
Advanced English, Project coordination, Continuous improvement focus, Regulated environment experience
Technologies
Lean Manufacturing, Six Sigma, 6S
Responsibilities
Manage manufacturing engineering needs; Develop, execute, and document process and equipment validations; Participate in and administer capital projects (CAPEX); Generate action plans for problem resolution and process deviations; Apply problem-solving methodologies and statistical analysis for continuous improvement; Identify and evaluate improvement opportunities considering cost-benefit; Develop and implement new manufacturing processes; Evaluate, acquire, and install new equipment and fixtures including preventive maintenance programs; Establish production standards and coordinate line balancing; Collaborate in evaluation and transfer of new products, processes, and raw materials; Update manufacturing area layouts; Update product material structures; Generate and maintain work procedures and instructions for manufacturing processes; Lead improvement, capacity increase, and cost reduction projects; Monitor trends of critical process and quality variables; Actively participate in Lean Manufacturing, Six Sigma, and 6S initiatives; Investigate and implement new technologies for products and processes; Implement controls for monitoring manufacturing processes; Generate requisitions for parts, consumables, and services; Support execution of equipment calibrations; Support manufacturing equipment maintenance activities; Ensure compliance with GMP, QSR, FDA, and internal procedures.
Seniority
Mid-level (3-5 years experience)