Artex Risk Solutions

Compliance

• Develop U.S., EU and Canada regulatory strategy and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status
• Evaluate the risk of proposed regulatory strategies and offer solutions, as applicable
• Advise and provide regulatory direction to assigned Product Development Team(s) on the regulatory requirements, documentation and testing needed for FDA, EU MDR & Health Canada regulatory submissions and registrations during the development of new devices, device modifications, and changes to existing products
• Prepare, write, and submit FDA, Notified Body and Health Canada submissions for new products and product changes as required in accordance with established time-lines and submission dates to ensure timely approvals while in compliance with regulations
• Partner with International Regulatory Affairs to provide regulatory support for new products and changes to existing products
• Provide business and product information to International Regulatory Affairs to enable development of strategies and communicate that information to assigned Product Development Team(s)
• Review and approve design control documentation, engineering change requests for design, manufacturing and labeling changes, and customs requests to ensure compliance with global regulations
• Provide feedback and on-going support to Product Development Team(s) to resolve (potential) regulatory issues and questions from regulatory agencies
• Rigorously review regulatory documentation to ensure completeness, clarity, consistency, and conformance to regulations and guidelines
• Coordinate and consult with manager and/or other departments on the content and review of regulatory documentation
• Provide support to currently-marketed products as necessary. This includes: reviewing labeling; reviewing promotional material; reviewing product changes; preparing documentation for changes requiring government approval; and preparing submissions and reports for regulatory agencies as required by product status
• Interact with FDA, Notified Bodies and/or Health Canada on products at reviewer level
• Establish, develop and maintain positive relationships with regulatory agency personnel
• Maintain proficiency in applicable regulatory requirements

Principal Specialist, Regulatory Affairs

Supply Chain

• Manage market demand plans, analyse trends, and incorporate commercial inputs to improve forecast accuracy.
• Support sales with tools and insights and regularly review parameters to enhance performance.
• Plan inventory levels to ensure product availability, address supply risks, and maintain strong communication with the global supply chain team.
• Monitor inventory and safety stock to reduce excess and obsolescence risk.
• Collaborate with product teams on phase-in and phase-out planning.
• Prepare materials and lead S&OP meetings to align demand forecasts with financial plans.
• Track and present monthly KPIs, recommend actions, and drive continuous improvement initiatives with cross-functional teams.

Senior Demand Planner

Software Engineer

• Supervises Product Development Engineers’ work activities to provide timely and efficient flow of services and projects.
• Maintains a leading edge understanding of the orthopedic industry, customers, and competitors in order to find new and novel opportunities to grow the business and reduce cost.
• Assists in hiring, developing and retaining the best talent for the engineering team and the organization.
• Actively provides coaching and career development assistance to team members.
• Assists in developing future leaders by effective selection and development activities.
• Assists in assessing new technology and new product ideas for technical and economic feasibility.
• Assists in evaluating and developing improved techniques for the control of product development activities.
• Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.
• Assists in overseeing the development of timelines for new product projects.
• Leads multifunctional new product project teams through feasibility, initiation, planning, execution, and termination, adhering closely to project timeline and budget.
• Maintains design history file for assigned projects, adhering to Arthrex design control procedures.
• Provides Regulatory department technical support for projects as needed.
• Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
• Supports Manufacturing vendors to provide processing improvements.
• Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
• Determines necessity of testing and initiates testing of assigned products.
• Reports progress and status of projects on a timely basis with emphasis on reporting results to the Director of Engineering.

Supervisor – Engineering, I&R

Operations

• Ensuring a consistent, high-quality customer experience within the Arthrex Experience (AX) visit programs at the EMEA headquarters in Munich
• Building scalable processes, tools and KPIs for visitor organization and resource planning
• Acting as the central point of contact for internal stakeholders regarding appointment coordination, logistics and quality assurance
• Continually improving visit processes through feedback management and data analysis
• Providing personal support to KOLs (Key Opinion Leaders) and delegations throughout the entire visit lifecycle
• Organizing and evaluating visit feedback and deriving optimization measures

Experience Operations Coordinator – EMEA

• Familiarization with advanced material models for all nonlinear finite element analyses and fatigue testing of orthopedic implants
• Testing various implant materials according to industry standards, collecting and analyzing data
• Simulating biomechanical tests on implants and validating the material models
• Developing best practices for simulation

Master's Thesis Student in Engineering

Electrical Engineer

• Designs electronic sub-systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
• Recommends alterations to development and design to improve quality of products and/or procedures.
• Determines budgets and timelines for assigned projects.
• Leads electrical design for multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget.
• Provides design history file support for assigned projects, adhering to Arthrex design control procedures.
• Provides Regulatory department with technical electrical support for assigned projects as needed.
• Supports Marketing and Product Management with electrical technical information to be used for training and marketing of assigned products.
• Supports Manufacturing to provide processing improvements.
• Supports surgeon and distributor customers by training and/or educating on electrical technical aspects of assigned products as needed.
• Determines necessity of electrical testing and initiates testing of assigned products.
• Reports on progress and status of assigned projects on a timely basis.
• May be required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.

Principal Electrical Engineer – Product Development, Medical Devices

Learning and Development

• Colaborar activamente en el desarrollo, implementación y mantenimiento de programas de capacitación en ventas.
• Desarrollar competencias en el equipo comercial de los diferentes canales de la compañía.
• Identificar las necesidades del cirujano y articular propuestas de valor de productos y soluciones relevantes.
• Aumentar el volumen y la rentabilidad de ventas en Latinoamérica.
• Trabajar con el líder directo para identificar necesidades y oportunidades de capacitación.
• Desarrollar y mantener un sistema para el seguimiento de los participantes de la capacitación.
• Coordinar, junto con el equipo de eventos, las sesiones de capacitación.
• Colaborar con la gerencia en el desarrollo, mantenimiento y actualización de los materiales del curso.
• Fomentar la comunicación entre departamentos y servir como contacto principal.
• Participar en la revisión anual de los programas de capacitación.
• Ayudar a identificar tendencias de aprendizaje nuevas y emergentes.
• Desarrollar y fomentar las relaciones comerciales con partes internas clave.
• Impulsar los objetivos departamentales.

Sales Training Specialist – LATAM

Engineer

• Provide Electrical Engineering support to ACT Production Operations, Quality Engineering, Supply Chain and Product Design teams to achieve business goals
• Develop and optimize electrical device testing methods, automated test equipment, statistical data collection, capacity scaling, failure analysis, and validation
• Support new product commercialization and ensure compliance with ISO 13485, FDA, electrical safety, and EMI/EMC requirements
• Develop, optimize, and document test methods for electronic equipment manufacturing
• Mentor test technicians and test engineers in troubleshooting, debugging, and root cause failure analysis
• Analyze test results in relation to specifications and adjust processes or equipment as needed
• Perform PCB, sub-assembly, and final device testing and/or troubleshooting
• Lead yield improvement initiatives using SPC, DOE, capability studies, and data-driven decision making
• Collaborate with suppliers and internal teams on test readiness, Failure analysis, CAPA, and continuous improvement
• Maintain and troubleshoot production equipment and tooling
• Support new product development/design transfer by leading process development and validations

Engineer I – Electrical Manufacturing

Financial Planning and Analysis

• Preparar el Budget anual y el análisis mensual de las variaciones que se presenten vs los Estados Financieros históricos.
• Dar soporte a las áreas involucradas en los planes de acción que elaboren para la remediación de estas desviaciones.
• Elaborar el presupuesto anual: a. Preparar las plantillas estándar para venta, CAPEX y OPEX.
• Distribuir las plantillas entre las gerencias responsables de proveer información.
• Recolectar en tiempo y forma la información.
• Consolidar y armar el paquete del presupuesto.
• Efectuar los análisis financieros para el área comercial: a. Análisis de márgenes (precios y costos).
• Análisis para la actualización de precios en conjunto con el área comercial.
• Modelaje financiero (ROI, PAYBACK y TIR).
• Preparar y presentar de los resultados financieros mensuales de la compañía (Estado de Resultados y Balance General).
• Generar y procesar información financiera, comercial y operativa para los diferentes proyectos, revisiones y/o actividades de SSC de Finanzas.