Who we are: Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients. We are looking for new members of our team who already live by our shared values and are inspired by our company's Vision. Accelerate the evolution of brain science and technology by delivering advanced solutions to help end patients suffering from brain pathologies; and our Mission. Revolutionize the understanding of the brain through new personalized neuromodulation therapies, anywhere and at any time.Position Summary: Responsible for supporting technology transfer initiatives to ensure the process efficiency for cGMP planning and implementation are conducted. Needs to plan, execute, and track progress of approved projects using assigned resources. Support in optimizing all the production system operations, as well as supporting in ensuring the proper quality and cost reduction.What will you do: Reporting to the Production & Supply Chain Director, the main responsibilities of the role are:Create, update and supervise production documentation materials (manufacturing drawings, procedures, test reports, etc.)Gains and manages alignment on project objectives from all stakeholders.Creates and coordinates the new item introduction of raw materials, components, and products into the enterprise resource planning tool by working with production planning.Resolves conflicts and removes roadblocks to project execution.Reports on project status, risks, and emerging needs.Sets milestones and defines deliverables.Improve our current quality control process by identifying the key parts of the components that need to be inspected and define inspection methodology in a production scale.Collaborate with the Supply Chain and providers, by defining the key parameters of the subcontracted process.Collaborate with the Engineering department for definition of documentation and validation of manufacturing processes.Supports the drafting and updating of the process technology transfer protocols.Support the Production Director in diagnosing problems in the production line and providing recommendations.Support on the redesign of the production process for its optimization in time and cost.Support the Production Director on ensuring that all the production equipment is calibrated and properly maintained (including but not limited to documentary stage).Collaboration on the implementation of Lean Manufacturing.Work on the identification and documentation of product related complaints, non-conformities, development of CAPA plans, with both internal and external stakeholders.Perform other duties as assigned.Comply with and enforce compliance with established information security and privacy policies and standards and act in accordance with instructions and procedures received.What do you need:University degree in an applicable engineering field (i.e. Electronic/Electrical Engineering, Industrial Engineering, Telecommunications Engineering, etc.)Proficiency with PC computer and Microsoft Office softwareFluent in English both written and oralKnowledge of Project Management practices, tools, and terminology (PMBOK or similar)Ability to learn quickly and solve complex challenges with creative solutions.Passionate about optimization and standardization of process.Attention to detailData driven. Strong MS Office skills.Critical Thinking and logic skillsUnderstanding of quality standardsYou will be the perfect fit if you are/have:Valuable:Formal training in Project Management (e.g. PMI certification)Experience/knowledge in medical devices in the context of ISO 13485/ DGMP is a plus.Experience in Lean manufacturing and six sigma methodologies is a plus.Knowledge of Quality System (e.g., Auditing, Change Control, Complaints, Deviations, CAPAs, Batch Record Review, Documentation management, Training, Supplier Management, validations, qualifications, calibrations).Knowledge of common electronic component parameters and PCB manufacturing.Knowledge of product documentation for design controls, risk management, and production.Experience in an ERP. Experience in Odoo is a plus.Experience in SQL & PowerBI knowledge is a plus.Skills:Passionate about making a difference, gifted with a can-do attitude.Reliable, Responsible, and Respectful.Good communication and presentation skills.Ability to adapt and work effectively within a rapidly changing and growing environment.Entrepreneurial spirit.
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