Working at Freudenberg: We will wow your world! Responsibilities: Lead development of accurate manufacturing cost models, make-vs-buy decisions, work-center costs, and support quote generation and pricing strategy for new business or large sustaining initiatives. Establish, track, and report key performance metrics for development, project progression, and launch; champion continuous-improvement and Lean/Six Sigma activities to boost quality, delivery, and cost. Gather and translate user, customer, clinician, and/or market needs and inputs into clear product and business requirements; present data-driven recommendations to stakeholders. Maintain project documentation in line with internal procedures and notified-body expectations, supporting audits and ensuring robust change-control and traceability. Prepare reports and project summaries to communicate the status of projects on a regular basis. Provide technical and project-management leadership, set priorities, allocate tasks, mentor team members, and foster a culture of efficiency, innovation, and regulatory excellence across the organization. Manages a few discrete projects with teams, operating within a defined PDP process delivering to achieve defined scope, schedule, and budget performance goals. Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements. Input and review for design history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes, equipment, and products meet client, regulatory, and business needs.