The primary purpose of the Manufacturing Engineer II position is to apply engineering principles to drive process improvements in the manufacturing of medical devices while positively affecting quality, delivery, cost, safety, and morale. We seek a candidate with a positive attitude, excellent attention-to-detail, and a strong desire for professional growth.
Main Responsibilities
? Adhere to core values and all safety and quality requirements, including QMS, EMS, FDA regulations, company policies, and other regulatory requirements.
? Develop and execute process and test method validations (IQ, OQ, PQ, PPQ).
? Prepare or review documentation with high accuracy and completeness using common engineering tools and templates.
? Create and implement lean processes in a cellular environment utilizing methods such as machining, welding, finishing, cleaning, assembly, and inspection.
? Communicate ideas, information, and recommendations clearly within the company and with external suppliers, partners, and customers.
? Apply DMAIC-Six Sigma approaches to solve issues and reduce variation in all manufacturing and business processes.
? Plan and execute project activities within a cross-functional team for various project types, including new product development, manufacturing transfers, continuous improvement, and cost reduction initiatives.
? Investigate, develop, and implement new process technologies using Lean Manufacturing techniques to improve cycle times and process flows.
? Collaborate with development, programmers, machinists, and suppliers to evaluate designs for manufacturability and cost reduction.
? Demonstrate leadership through mentoring peers and responding to business needs to achieve positive results.
? Ensure internal and external customer expectations are met or exceeded.
? Create and execute validation protocols, processes, and material evaluations.
? Support the maintenance team as needed to troubleshoot equipment issues.
Position Requirements
? 3-5 years of experience in a regulated industry.
? Bachelor's degree in engineering or a technical field with applicable experience.
? Lean manufacturing and new product development or launch support experience is highly desirable.