Working at Freudenberg: We will wow your world! Responsibilities: Lead and manage new product introduction (NPI) projects from concept through commercialization, including project planning, budgeting, resource management, and stakeholder communication. Drive the design, development, prototyping, and testing of new medical devices, ensuring compliance with customer requirements, design inputs, and applicable regulatory standards. Oversee design verification and validation, process validation (IQ/OQ/PQ), and test method development, ensuring robust, compliant, and scalable manufacturing processes. Collaborate cross-functionally with product development, quality, manufacturing, regulatory, customers and suppliers to ensure design for manufacturability (DFM), risk management (PFMEA), and smooth design transfer to production. Provide technical leadership and mentoring to less experienced engineers, guiding problem-solving, process improvements, and quality initiatives to support continuous improvement. May supervise a small team of Engineer I or Technician colleagues. Lead risk management activities, including the development of risk analysis, validation protocols, and quality control plans to ensure product and process compliance. Utilize statistical tools (DOE, SPC, Minitab) to analyze data, improve process capability, and support quality decision-making; manage nonconformance, CAPA, and change control processes. Support and participate in supplier qualification, vendor assessments, customer communication, and regulatory audits while ensuring alignment with ISO, applicable regulatory and company standards. Support new business acquisition through the quotation process. Define and control production process including tooling and equipment. Validate design specifications and shop floor application of new product, tools, or equipment. Working closely with Operations team to ensure all facilities are prepared for new product launches. Define Capex needs for and scalability plans, including facility planning for new product launches.