Emanuel L.

Experience

• Founder & Technical Lead LEMMA Engineering & Design · Self-employed Jan 2023 – Present 3 yrs 1 mos Campo Largo, PR, Brazil STRATEGIC ADVISORY FOR MEDICAL DEVICE MANUFACTURERS.
  
  
  RESEARCH & DEVELOPMENT (R&D) ADVISORY From initial concept to global market access, I provide end-to-end engineering support:
  
  🔹Design & Engineering: Project scoping, advanced 3D Design, and GD&T technical drawing.
  
  🔹Risk & Compliance: ISO 14971 Risk Management and preparation of technical documentation for CE (Technical File), FDA (510k), ANVISA, and DIGEMID submissions.
  
  🔹Validation & Documentation: Design validation methods, technical control documentation, and creation of high-precision Instructions for Use (IFUs).
  
  🔹Digital Solutions: Processing of digital files and development of customized CAD/CAM libraries.
  
  🔹Audit Support: Preparation of technical documentation for internal and external audits.
  
  MANUFACTURING & PRODUCTION ADVISORY Optimizing production lines for efficiency, quality, and scalability:
  
  🔹Strategic Outsourcing: Vendor selection and management for outsourced services.
  
  🔹Process Engineering: Development of production procedures, quality assurance protocols, and continuous improvement initiatives.
  
  🔹Industrial Tooling & Devices: Design and specification of specialized tools and production fixtures, including high-precision calibrators and measurement supports.
  
  🔹Operational Excellence: Comprehensive project follow-up and technical supervision of manufacturing processes.
  
  COMMERCIAL & MARKETING ADVISORY Bridging the gap between complex engineering and high-impact sales assets:
  
  🔹Visual Marketing: High-end 3D animations and photorealistic catalog design, including technical specifications in English, Spanish, and Portuguese.
  
  🔹Technical Presentations: Creation of professional PowerPoint presentations and technical sales materials.
  
  🔹Trade Fair Support: Technical advisory and support for product showcases at international exhibitions.
• R&D Coordinator DSP Biomedical Group · Full-time Jun 2022 – Nov 2022 5 mos Campo Largo, PR, Brazil R&D Leadership & Strategy: Spearheaded the Research and Development department, defining strategic goals and tracking performance KPIs to ensure alignment with company objectives. | Executive Management: Participated in high-level board meetings (C-suite level) to define product roadmaps and business strategies. | Team Talent Management: Led recruitment, hiring, and career development planning for the R&D sector, including technical training and performance evaluations. | Multidisciplinary Collaboration: Orchestrated meetings with cross-functional teams and provided specialized technical training for Marketing and Sales departments to enhance product positioning. | Regulatory & Quality Compliance: Acted as the primary technical respondent during regulatory audits, ensuring all processes met international standards. | Product Lifecycle & DfM: Oversaw product scope, risk management, 3D/2D design validation, and manufacturing process optimization. | Operations & Troubleshooting: Managed production workflows, technical documentation, and complex problem-solving to ensure industrial and commercial excellence.
• R&D Project Designer DSP Biomedical Group · Full-time Jun 2019 – Jun 2022 3 yrs Campo Largo, PR, Brazil Product Scope & Strategy: Defined product scope and led risk management processes in collaboration with multidisciplinary teams. | Design & Prototyping: Created high-fidelity 3D models, 2D technical drawings, and functional prototypes for design validation. | Manufacturing Engineering: Defined manufacturing processes, control methods, and production workflows to ensure scalability. | Validation & Training: Conducted prototype validation and provided technical training for manufacturing teams. | Technical Documentation: Managed technical files and authored regulatory documentation for industrial, commercial, and training purposes. | Problem Solving: Led troubleshooting initiatives and optimized production processes to resolve complex manufacturing issues.
• Quality Inspection Supervisor DSP Biomedical Group · Full-time Feb 2018 – Jun 2019 1 yrs 4 mos Campo Largo, PR, Brazil R&D and Instrumentation: Developed automated and manual measurement devices focused on cost reduction, efficiency, and usability. | Quality Operations: Managed product and raw material release/quarantine, ensuring full traceability and technical report generation. | Metrology & Training: Programmed CMM (Multi-sensor Measuring Machines) and provided technical training for operators. | Risk Management: Managed product and process Risk Management according to ISO 14971 standards. | Compliance & Audits: Led internal audits and provided technical support for external regulatory audits (FDA/CE/ANVISA). | Performance Reporting: Reported key statistics and quality performance indicators (KPIs) to the executive board and production management. | Team Leadership: Led a team of 7 quality inspectors.
• Mechanical Technician DSP Biomedical Group · Full-time May 2016 – Feb 2018 1 yrs 9 mos Campo Largo, PR, Brazil Technical Leadership & Project Management: Spearheaded technical projects and production planning, ensuring seamless execution across diverse manufacturing sectors. | Team Coordination: Led a production team of 14, streamlining hiring processes and optimizing operational workflows to meet KPIs. | Supply Chain & Outsourcing: Orchestrated strategic outsourcing for specialized processes, including machining, laser cutting, stamping, and surface treatments. | Strategic Partnership: Partnered with Marketing to enhance brand positioning by delivering technical specifications and high-quality visual assets.
• CNC Machine Operator II FGM Dental Group · Full-time Jun 2011 – Aug 2015 4 yrs 2 mos SC, Brazil Design & Engineering: Executed high-precision 3D component modeling and 2D technical drafting using SOLIDWORKS, ensuring seamless integration between R&D and the machining department. |
  
  Precision Manufacturing: Expert in programming and operating multi-axis CNC centers (up to 5-axis), ensuring the production of complex medical components with strict tolerance control. |
  
  Advanced Metrology: Conducted high-level dimensional inspection and quality control utilizing Werth CMM (Coordinate Measuring Machine) technology. |
  
  Process Optimization: Optimized production cycles by managing tool inventory and lifecycles, leveraging performance data to drive manufacturing efficiency. |
  
  Control Systems: Advanced proficiency in FANUC and SIEMENS systems, with a proven track record of troubleshooting and stabilizing complex machining processes. |
  
  Compliance: Authored Standard Operating Procedures (SOPs) and mentored junior engineering teams to ensure safety, operational excellence, and regulatory compliance.