Position Summary: Designs, develops, and optimizes manufacturing processes for medical devices, leading validations and improving process capability. Key Highlights: 1. Experience in medical device process engineering 2. Leadership in process validation and transfer 3. Collaboration with quality and regulatory teams Description and details of responsibilities **Key Responsibilities** * Design, develop, and optimize manufacturing processes for medical devices. * Lead process validation activities (IQ, OQ, PQ, and PPQ). * Characterize, scale, and strengthen processes using DOE, SPC, Six Sigma, and Lean principles. Perform process FMEA, root cause analysis, and problem-solving to improve process capability (CpK ≥ 1.33). * Coordinate process transfers from R&D to production, ensuring manufacturability and regulatory compliance. * Collaborate with Quality and Regulatory teams to integrate process controls into the QMS and support regulatory submissions (e.g., 510(k)). * Implement continuous improvement initiatives focused on efficiency, cost reduction, and cycle time improvement. * Oversee qualification of equipment, tooling, and external suppliers. * Provide technical support for New Product Introduction (NPI) activities. * Mentor and support junior engineers, promoting best practices and knowledge transfer. Experience and requirements **Experience** * Minimum of 3 years of experience in process engineering within the medical device industry. * Proven experience in process validation, technology transfer, and manufacturing scale-up. * Direct involvement in New Product Introduction (NPI) projects. * Experience working in FDA-regulated environments; Class II or III medical devices preferred. **Education** * Bachelor’s degree in Mechanical, Biomedical, Chemical Engineering, or a related field. * Master’s degree and/or Six Sigma Black Belt certification preferred. **Skills and Competencies** * Strong knowledge of Lean Manufacturing and Six Sigma methodologies. * Proficiency with DOE, SPC, and statistical analysis tools (e.g., Minitab). * Solid understanding of regulatory standards such as 21 CFR 820 and ISO 13485. * **Advanced English (written and verbal) is required for technical communication with global teams and customers.** * Strong analytical and data-driven problem-solving skills. * Effective communication and collaboration skills in cross-functional environments. * Technical leadership, mentoring capability, and ability to manage multiple projects in dynamic settings. Benefits * Benefits according to LFT * Life insurance * Transportation * Uniform * Guaranteed profit sharing * Savings fund * On-site medical services * Cafeteria * Life insurance * Savings fund * Cafeteria * Transportation * Uniform * Gym * Medical expense insurance **Number of vacancies** 1 **Department** Engineering **Contract type** Temporary **Work modality** On-site **Shift** Day **Working hours** Full-time **Schedule** Full-time **Education** Professional degree **English** Spoken: Advanced, Written: Advanced **Willingness to travel** No