In this role, you will lead complex manufacturing process design and improvement activities to ensure the safety and efficacy of components and finished medical devices. You will independently lead qualification, verification, and validation (QVV) of manufacturing processes, equipment, and product lines for medical device production. Your responsibilities will include troubleshooting and resolving issues related to product safety, quality, cost, delivery, and process performance. You will drive engineering initiatives and new product development, including technology development, process studies, Six Sigma projects, materials testing, and intellectual property generation. Additionally, you will design and develop manufacturing equipment in compliance with safety regulations such as OSHA and EPA standards. Participation in design control efforts, including risk analysis (FMEA), design reviews, and validation protocols will also be part of your duties. You will lead supplier sourcing and evaluation efforts to assess capability, quality, and effectiveness of external partners and service providers. Directing controlled environment operations, including cleanroom design, equipment maintenance, and troubleshooting, will be essential. You will mentor and train cross-functional teams, including engineers, technicians, and operators, while also supporting post-market surveillance and product performance reviews. Finally, you will lead and coordinate cross-functional project teams, manage timelines, define goals, evaluate engineering tests and experiments, and identify opportunities for process optimization and cost savings.