Amoveri Hub · OutsourcedJul 2021 - Present · 2 years 5 monthsJoinville, Santa Catarina, Brazil · HybridIn my role as Innovation Executive, I lead initiatives that transcend boundaries and encompass areas such as robotics, business digitization, RPA, automation/IoT, process logistics, R&D, and bioelectronics systems. My responsibilities include identifying innovation opportunities, conceiving and developing projects, establishing strategic partnerships, managing intellectual… Show more Amoveri Hub · OutsourcedJul 2021 - Present · 2 years 5 monthsJoinville, Santa Catarina, Brazil · HybridIn my role as Innovation Executive, I lead initiatives that transcend boundaries and encompass areas such as robotics, business digitization, RPA, automation/IoT, process logistics, R&D, and bioelectronics systems. My responsibilities include identifying innovation opportunities, conceiving and developing projects, establishing strategic partnerships, managing intellectual property, and analyzing results. With my extensive project experience, I am capable of leading multidisciplinary teams and collaborating with external companies and organizations to develop solutions that drive growth and competitiveness. Show less

UIRTOS Regulatory Services · OwnerJun 2020 - Present · 3 years 6 monthsAs a Director and Regulatory Affairs Specialist, I provide specialized services for research, development, innovation, and the regulatory approval of medical companies and products in the European Market, USA, ANVISA, and INMETRO.▪ I offer specialized services in the regulation of medical companies and products to ANVISA and INMETRO, including document preparation for the regulation of medical products, such… Show more UIRTOS Regulatory Services · OwnerJun 2020 - Present · 3 years 6 monthsAs a Director and Regulatory Affairs Specialist, I provide specialized services for research, development, innovation, and the regulatory approval of medical companies and products in the European Market, USA, ANVISA, and INMETRO.▪ I offer specialized services in the regulation of medical companies and products to ANVISA and INMETRO, including document preparation for the regulation of medical products, such as clinical analysis, clinical research, usability engineering, software validation, life cycle, shelf life, cleaning/sterilization validation.▪ I provide technical consultancy for product safety design, review and generation of labeling, and assistance in the selection and review of safety-critical components subject to component reliability. I also engage in support activities and interface with testing agencies and certifying bodies.▪ We offer engineering usability services with our own framework, covering everything from the initial concept (TRL1) to production release (TRL9), with the possibility of post-market monitoring. Our services include product lifecycle assessment, risk analysis, usability testing, and user feedback to ensure that products meet user needs and comply with applicable regulatory standards. We are committed to providing customized solutions for our clients in the medical sector, always striving for excellence. Show less

RA Passarini · Full-timeMar 2016 - Feb 2020 · 4 yearsRemote▪ Regulatory services for medical companies and products with ANVISA/INMETRO, document preparation for the regulation of medical products, such as Clinical Analysis, Clinical Research, Usability Engineering, Software Validation (62304 and FDA), Life Cycle, Shelf Life, Cleaning/Sterilization Validation, Transport Validation, and Risk Management. Registration services and FDA Agent for the FDA.▪ Providing support for… Show more RA Passarini · Full-timeMar 2016 - Feb 2020 · 4 yearsRemote▪ Regulatory services for medical companies and products with ANVISA/INMETRO, document preparation for the regulation of medical products, such as Clinical Analysis, Clinical Research, Usability Engineering, Software Validation (62304 and FDA), Life Cycle, Shelf Life, Cleaning/Sterilization Validation, Transport Validation, and Risk Management. Registration services and FDA Agent for the FDA.▪ Providing support for medical product safety design projects (mainly for IEC 60601-1), including gap analysis/project construction evaluation, review and generation of product labeling and marking, assistance in the selection and review of critical safety components. Support activities/interface with Testing Agencies and certified bodies.▪ Providing services to set up/maintain an appropriate Quality System to meet ISO 9001, ISO 13485, CFR 21, MDD, and MDR requirements and conducting audits for quality management systems.▪ Generating/reviewing technical files, essential requirements checklists, risk analysis in accordance with ISO 14971 for European directives (MDD, LVD, EMC, MDR), ANVISA, INMETRO, FDA, and generating/reviewing SOPs, validation processes, clinical evaluation, risk analysis/FMEA, Usability Engineering, Medical Software Validation, and Computerized System Validation. Show less

Jun 2016 - Dec 2017 · 1 year 7 monthsDuring my time at DNV GL - Business Assurance Brazil, I served as an Auditor, where I gained a deep understanding of crucial topics related to the regulation of medical products. My main focus was on ensuring the safety and quality of products and processes in compliance with applicable standards and regulations.Risk Management:One of the central areas of my work at DNV was risk management. This involved a thorough analysis of risks… Show more Jun 2016 - Dec 2017 · 1 year 7 monthsDuring my time at DNV GL - Business Assurance Brazil, I served as an Auditor, where I gained a deep understanding of crucial topics related to the regulation of medical products. My main focus was on ensuring the safety and quality of products and processes in compliance with applicable standards and regulations.Risk Management:One of the central areas of my work at DNV was risk management. This involved a thorough analysis of risks associated with medical products, from development to the use of the product by patients. My role was to assess and apply risk management methodologies, with a particular focus on risk analysis according to ISO 14971. This was essential to ensure the safety and effectiveness of medical products in compliance with international standards.Usability:My experience at DNV also allowed me to develop deep knowledge in the usability of medical products. This included evaluating the usability of medical devices, ensuring they met user needs and complied with applicable regulatory standards. Additionally, I participated in usability testing and user feedback collection to enhance the user experience.Medical Software Validation:In a strict regulatory environment, the validation of medical software plays a critical role. At DNV, I was responsible for handling medical software validation, including compliance with standards such as ISO 62304 and FDA. This required a detailed review of documents, processes, and software systems to ensure they complied with standards and regulations. Show less

In my role as Engineering Coordinator at KaVo, I had the opportunity to lead teams of engineers and technicians and oversee a series of challenging projects in the development of dental-medical products. During this period, my responsibilities extended beyond project management to encompass the supervision of design activities, prototyping, testing, validation, documentation, and regulatory approval.My results-focused leadership approach ensured that projects were aligned with strategic… Show more In my role as Engineering Coordinator at KaVo, I had the opportunity to lead teams of engineers and technicians and oversee a series of challenging projects in the development of dental-medical products. During this period, my responsibilities extended beyond project management to encompass the supervision of design activities, prototyping, testing, validation, documentation, and regulatory approval.My results-focused leadership approach ensured that projects were aligned with strategic goals and delivered within the agreed scope, cost, and schedule. Additionally, I provided essential technical support to various departments within the company, including production, procurement, and post-sales, ensuring everyone was aligned with the project's objectives.Identifying and managing technical risks and issues were integral parts of my role, and I made strategic decisions to ensure the success of the projects. This involved staying updated on technological and regulatory trends in the dental-medical industry, allowing me to guide the company's strategy and the development of new products.One of my additional responsibilities included overseeing laboratory tests, conducting internal audits, and managing external audits. Additionally, I played a key role in conducting product safety tests and participating in project Safety Audits.Overall, my experience at KaVo as an Engineering Coordinator allowed me to enhance my skills in coordinating multidisciplinary teams, managing complex projects, and making strategic decisions. This experience enriched my leadership capability and deepened my understanding of the nuances of the dental-medical industry. Show less

As an Engineer in Product Development at Whirlpool Corporation, I worked on the electronic development of new appliances under the Brastemp, Consul, and KitchenAid brands. My role involved adapting products to meet the regulatory requirements of the ABNT NBR IEC 60335-1 series and specific standards, including UL 250 / UL 258, Whirlpool Product Safety standards, and certifications for international markets.I ensured that projects were delivered within the agreed scope, cost, and… Show more As an Engineer in Product Development at Whirlpool Corporation, I worked on the electronic development of new appliances under the Brastemp, Consul, and KitchenAid brands. My role involved adapting products to meet the regulatory requirements of the ABNT NBR IEC 60335-1 series and specific standards, including UL 250 / UL 258, Whirlpool Product Safety standards, and certifications for international markets.I ensured that projects were delivered within the agreed scope, cost, and timeline by monitoring project indicators, managing the necessary resources (financial, human, and material), and applying appropriate project management methodologies. I coordinated internal clients and departments, managed conflicts, and communicated decisions and results.I was responsible for developing DFMEAs and product maps for my projects, as well as quality improvement projects. I oversaw and conducted product safety tests and participated in project Safety Audits.Additionally, I conducted laboratory tests for international appliance standards, such as IEC and UL, as well as proprietary safety methodologies of Whirlpool.I also led Lean Manufacturing projects and Six Sigma tests, including the coordination of electrical, mechanical, civil, and hydropneumatic aspects of the new product development laboratory in the Joinville plant.I held different positions during my time at Whirlpool:Senior Engineer in Product Development (08/2006 to 09/2009)Junior Engineer in Product Development (09/2003 to 08/2006)Product Development Engineer Trainee (03/2003 to 09/2003)P&D Laboratory Intern (02/2002 to 03/2003)My competencies included concept generation, intellectual property management, stakeholder management, risk management, leadership of cross-functional teams, product development, and project management. Show less