PROCESS ENGINEERING SPECIALIST

Description

Job Summary: We are seeking a professional to analyze and improve manufacturing processes, serving as a technical reference for medical devices and ensuring regulatory compliance. Key Highlights: 1. Strategic involvement in improving medical device manufacturing processes 2. Technical reference for compliance with ANVISA, FDA, and MDR 3. Leadership in continuous improvement initiatives focused on quality We seek a professional to analyze and improve manufacturing processes, serving as a technical reference for medical devices and ensuring compliance with ANVISA, FDA, and MDR, as well as safe and reliable processes. **Responsibilities and Duties** * Conduct process and equipment validations (IQ, OQ, PQ), per regulatory requirements (ANVISA, FDA, and MDSAP). * Develop and review validation protocols and reports, ensuring traceability and readiness for audits. * Develop, optimize, and monitor manufacturing processes, ensuring capability, repeatability, and stability. * Define and validate Critical Process Parameters (CPPs) and acceptance criteria based on risk analysis. * Support regulatory submissions (ANVISA and MDR), ensuring processes are properly qualified. * Conduct risk analyses (FMEA) and implement controls for mitigation. * Lead continuous improvement initiatives focused on quality, cost, and productivity. * Perform capability studies (Cp/Cpk), time-and-motion studies, and production flow analysis. * Specify, qualify, and validate new equipment, ensuring technical and regulatory compliance. * Monitor performance indicators and implement corrective and preventive actions. * Serve as the technical reference during internal and external audits (ANVISA, Notified Bodies, and MDSAP). **Requirements and Qualifications** * Bachelor's degree in Production, Mechanical, Biomedical, Electrical, Materials, or Chemical Engineering. * Experience in process validation and equipment qualification (IQ/OQ/PQ). * Experience in the medical device sector, preferably orthopedic implants. * Knowledge of regulatory requirements (ANVISA, FDA, and MDR). * Experience with MDSAP. * Proficiency in FMEA, SPC, capability analysis, and continuous improvement tools (Lean and Six Sigma). * Experience with technical documentation and audit support. * Fluent English. **Additional Information** * Health plan fully covered by Neoortho; * Dental plan; * Annual Flu Vaccination Campaign; * Life insurance; (including funeral assistance) * Wellhub (Gympass); * Access to Pluxee Cuida (psychological support, financial education, legal consulting, and nutritional guidance); * On-site cafeteria; * Transportation allowance; * Fuel allowance; * Meal allowance; * Pharmacy card; * Daycare assistance; * Neoortho Baby Kit (benefit for new parents); * Discount club; * Partnerships with educational institutions; * Private pension plan NEOPrev; * Scholarship program; * NEOArena leisure space; * Profit-sharing program (PPR); * Celebration of special occasions; * Birthday day off; * Birthday gift card; * Job and compensation program. We are a strategic healthcare partner, working side-by-side with surgeons, distributors, and institutions to deliver safe, technology-driven, reliable, and cost-effective healthcare solutions. Our portfolio offers comprehensive solutions across Traumatology, Craniomaxillofacial, Spine, and customized prostheses. Headquartered in Curitiba, Brazil, NeoOrtho joined the Medartis Group in March 2025, strengthening its infrastructure, technological capabilities, and global market presence. **Explore our opportunities and join our team!**