Domico Med-Device LLC

JOB SUMMARY Lead contract manufacturing projects from concept through production, ensuring robust process design, manufacturability, and ongoing improvement. Support production teams, drive continuous improvement, maintain compliant documentation, and collaborate directly with customers and cross-functional teams. Ensure all processes and specifications meet QMS, FDA 21 CFR Part 820, and ISO 13485 requirements. PRINCIPLE RESPONSIBILITIES AND RESULTS Contract Design & Development Lead design and development for OEM/contract manufacturing projects. Manage prototypes, first articles, design risk mitigation, and product testing. Apply DFM principles and create/maintain design documentation (DHF, DMR, V&V, FMEAs). Verify design outputs vs. inputs and support quality planning. Lead project timelines, milestones, and cross-functional meetings. Contract Manufacturing Lead (OEM projects) Evaluate new or revised product designs for manufacturability and...

JOB SUMMARY Drive continuous improvement efforts to increase efficiency and lower potential for scrap. Ensure manufacturing processes are accurate and appropriate for converting engineering design specifications to a product that achieves customer requirements; coordinate cross functionally as appropriate. Support personnel on any production related issues such as processing problems or document non-conformances. Develop, document and utilize proven manufacturing processes; conduct and document process capabilities as appropriate. Support and or engage in direct communication with customers to understand product to improve design for manufacturability and align process capability. Control product and process specifications to comply with quality management system ("QMS"), FDA 21 CFR Part 820, and ISO 13485 requirements. PRINCIPLE RESPONSIBILITIES AND RESULTS Continuous Improvement Use LEAN Manufacturing principles and other methods to identify and implement cost savings...