Experience

Neuroelectrics

• Spain
• Medical Device
• 1 - 100 Employee

• Senior Project Manager

  • Apr 2023 - Present

  - Implement and maintain project management methodologies, frameworks, and best practices.- Lead projects involving complex neuroscience devices, from development to clinical trials and regulatory submissions (FDA and MDR).- Provide project governance and ensure adherence to organizational standards and policies.- Monitor and report project performance, including tracking key metrics and KPIs.- Support the development and implementation of project management tools and software.- Provide training and mentorship to project managers and team members on project management principles and practices.- Contribute to writing proposals for the European International Council accelerator program.- Act as a key contributor in the development and implementation of product design and development processes, risk management protocols, and change control management procedures within the quality management system (ISO13485). Show less

• Engineering Project Manager

  • Mar 2022 - Apr 2023

  - Oversee and manage multiple projects simultaneously, ensuring their successful execution and completion within established timelines, budgets, and quality standards (ISO13485, ISO14971, ISO10993, IEC60601, IEC62304, IEC62366, etc.)- Provide leadership and guidance to project teams, assigning responsibilities and monitoring progress.- Collaborate with cross-functional teams to align project goals, resources, and priorities.- Develop and maintain project plans, defining scope, objectives, and milestones.- Identify and mitigate risks and issues, implementing contingency plans as needed.- Foster effective communication and collaboration among project team members and stakeholders.- Bring a broadened business perspective to each project through an understanding of the inner-workings of Marketing, Engineering, Clinical Operations, Regulatory Affairs, Quality, Manufacturing and Logistics Show less



MicroPort CRM

• France
• Medical Equipment Manufacturing
• 400 - 500 Employee

• Field Clinical Trials Specialist

  • Jan 2020 - Mar 2022

  Clinical trials and technical specialist in the Cardiac Rhythm Management branch of Microport (mainly Pacemakers, ICDs and CRTs). - Assist clinical sites / investigators in successful execution of Clinical Trials - Provide technical support to doctors and hospital personnel during cardiac devices implant procedures and follow-ups - Ensure timely submission of protocol / consent document for EC/IRB approval - Perform site training and clinical studies start-up (SIVs) - Collaborate with CRA and monitoring to ensure site data compliance and integrity - Develop strong relationship with doctors and investigators - Transfer knowledge and ideas from investigators to new product development Show less



Món e-commerce

• Barcelona, Catalonia, Spain

• Founder

  • Sep 2019 - Sep 2021

  - Founded and successfully established an e-commerce company specializing in yoga and meditation products, overseeing all aspects of the business from inception to growth. - Conducted market analysis to identify target audiences, assess competitors, and determine optimal product offerings, resulting in strategic business decisions and targeted marketing campaigns.- - Established and nurtured relationships with international providers, negotiating favorable terms and sourcing high-quality products, ensuring a diverse and competitive product portfolio. - Implemented efficient supply chain management processes, optimizing inventory management, order fulfillment, and logistics to ensure timely delivery and customer satisfaction. Show less



StarFish Medical

• Canada
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Technical Lead

  • Feb 2017 - Sep 2019

  - Guide device technical design, problem solving, experimentation, and testing- Lead the Design History File (DHF) documentation effort following the company's Quality Management System (QMS) and ISO13485 requirements - Lead technical content of FDA 510(k) regulatory submissions, and support the development of regulatory strategies- Develop manufacturing strategy, and evaluate and improve assembly processes- Support and review of human factor activities (e.g. usability testing with end users)- Plan for integration and systems level testing- Communicate with clients on a regular basis to provide technical updates and work through timeline and technical risk challenges- Resource projects and assign and manage tasks within budget, schedule and quality expectation- Scope and estimate remaining time, project change requests and new statements of work- Develop new business proposals Show less

• Project Manager / Mechanical Engineer

  • Nov 2015 - Feb 2017

  - Prepare and maintain project risk registry and project plans, and set/adhere to milestones, deliverables and budgets- Ensure team meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion- Manage project resource planning- Manage client expectations and report on project progress regularly- Interface with Business Development to transfer new activities into Engineering- Support documentation requirements in accordance with ISO13485- Support design transfer to production and provide on-going Engineering support - Develop test plans, execute verification testing and write detailed test reports for a variety of products - Design of solid models, assemblies and detailed component drawings using SolidWorks Show less

• Mechanical Engineer

  • Apr 2013 - Nov 2015

  - Work with the product development team to create product specifications to meet customer requirements and mitigate risks.- Design for manufacturing (injection molding, over-molding, silicone molding, machining, rapid prototyping, laser cutting, sheet metal, casting), assembly (mechanical, gluing, in-line QC testing, snap fitting) and other secondary operations (pad printing, powder coating, painting, labeling, packaging). - Support documentation requirements in accordance with ISO13485 including but not limited to product specifications, risk analysis and verification test protocols. - Prepare suitable documentation for 60601-1 Electrical Safety Testing, 3rd Edition.- Develop Test Plans and Methods for a variety of Products. - Execute Verification Testing and Write detailed Test Reports. - Understanding of good documentation practices. - Create solid models, assemblies and detailed component drawings using SolidWorks. - Familiarity with tolerances for different manufacturing processes - Manage client expectations and report on project progress regularly. - Provide contributions to projects that lead to customer success.- Perform internal audits. Show less



Zimmer Biomet

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Systems Engineer

  • Sep 2012 - Feb 2013

  - Execute testing and reporting for regulatory submission for the iAssist Knee System (FDA 510(k) number: K141601) - Develop and design the company products, and define and execute test protocols for the product design verification and validation. - Interact with the software, instrument, electronic and test teams, and external collaborators. - Ensure that quality standards ISO13485 are followed during development to guarantee safety and efficacy. - Execute testing and reporting for regulatory submission for the iAssist Knee System (FDA 510(k) number: K141601) - Develop and design the company products, and define and execute test protocols for the product design verification and validation. - Interact with the software, instrument, electronic and test teams, and external collaborators. - Ensure that quality standards ISO13485 are followed during development to guarantee safety and efficacy.



École de technologie supérieure

• Canada
• Higher Education
• 700 & Above Employee

• Research Assistant

  • Feb 2010 - Oct 2011

  - Write the class notes for the course GTS503 – Health care technologies, standards and certification at École de technologie supérieure (ÉTS). - Develop a website dedicated to health care technologies. - Write the class notes for the course GTS503 – Health care technologies, standards and certification at École de technologie supérieure (ÉTS). - Develop a website dedicated to health care technologies.