Artex Risk Solutions

Administrative Assistant

• Supports ongoing projects of the department.
• Composes letters and memoranda from verbal direction or from knowledge of company policy or procedures.
• Prepares monthly, weekly and special or one-time reports or projects as requested by the management team.
• Works closely with various departmental to maintain accurate spreadsheets and databases
• May provide backup for reception during breaks, vacations and times of absence.
• Schedules conferences, appointments and writes minutes and notices as necessary.
• May assist in other administrative functions or special projects, including HR events.
• May be responsible for billing and expense report administration/auditing.
• Arranges catering for hosted events as necessary.
• Coordinates travel arrangements for staff as necessary.
• Assists with Charitable Events as needed.
• Coordinates department events (Team building, bowling, luncheons, holiday, etc.).

Supply Chain

• Implements supplier strategies & allocations in collaboration with NPD Supply Chain, Engineering, and Quality to ensure Arthrex requirements for quality, continuity of supply, and cost are met.
• Collaborates with all Arthrex divisions to optimize use of the supplier base.
• Manages critical meetings with suppliers on key strategic projects and issues.
• Directs the historical consumption analysis and the maintenance of the NAM region ACT product Demand Plan (forecast).
• Supports continual improvement of the S&OP process for the global ACT product Demand Plan.
• Responsible for developing, approving and enforcing all applicable policies and procedures.
• Manages critical Engineering change requests and determines disposition of inventory.
• Collaborates with NPD SC to transition products and components to Sustaining SC for production after design transfer.
• Manages Material Master administration including planning parameters/modifiers to ensure appropriate inventory levels are achieved and maintained.
• Serves as Operations liaison/expert for ERP and PLM system use and enhancement projects.
• Manages the sustaining SC Buyer Planner team.

Senior Manager – Supply Chain, Medical Devices

QA Engineer

• Ensures that appropriate Software (SW) Quality plans are made that include all stages of the software life cycle and support SW Quality Plan design.
• Validates key design inputs (i.e. usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs).
• Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design-related activities during the software lifecycle.
• Can lead quality-related problem-solving for software.
• Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions as necessary, as required.
• Act as a business partner, single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards.

Senior Engineer – Software QA – Design

Account Executive

• Analyze the market, develop a commercial strategy, and create, implement and monitor an action plan
• Prospect for and retain a customer base of healthcare professionals (biomedical engineers, surgeons, operating room managers/supervisors, etc.) within healthcare facilities
• Gather and analyze customer needs and advise them on our products

Endoscopy Sales Manager

Director

• Coordinate appointments and travel arrangements
• Maintain calendars and professionally prepare documents, presentations, and reports
• Liaise with internal departments and external partners
• Draft and review correspondence in German and English
• Welcome and assist visitors
• Organize Medical Education programs and events
• Support internal processes and compliance documentation
• Process expense reports and prepare budget overviews

Assistant to the Director of Medical Education, EMEA

• Achieve predetermined sales goals and quotas
• Establish and maintain customer relations through communications and in-person appointments
• Maintain expert knowledge of market-leading product portfolio
• Consult surgeons in the operating room regarding the use of Arthrex products
• Increase territory results by building strong business relationships and implementing sales strategies
• Communicate with customer accounts regarding product updates and educational programs
• Implement new sales plans and effective marketing strategies
• Cross-sell additional products or manage new product introductions
• Address problems that arise at accounts
• Support compliance and maintain confidentiality of information
• Receive coaching, training or mentoring from sales manager
• Maintain training in sales skills and product features
• Collect competitive data and remain current on industry trends
• Participate in sales meetings and professional association meetings

Orthopedic Associate Sales Representative

• Achieve predetermined sales goals within assigned territory
• Build and maintain customer relations through communication and in-person appointments
• Consult surgeons in operating room regarding implants and instruments
• Implement new sales plans and marketing strategies

Orthopedic Sales Representative

• Analyser le marché et élaborer une stratégie commerciale
• Développer la relation commerciale avec les professionnels de santé
• Apporter expertise technique et formation au bloc opératoire
• Mettre en place des actions commerciales et développer les ventes
• Établir des rapports de visite clients et un reporting quotidien

Responsable Commercial – Extrémités, Traumatologie

Engineer

• Examine and Segment medical data in the form of radiographs, computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, and other relevant data for design use.
• Collaborate in all phases of the 3D model creation process including initial segmentation, model refinement, creation of CAD based modular features, materials settings, and assigning 3D printing settings, and laboratory testing.
• Utilize CAD software and skills to create modular structures of differing anatomies, as well as replacable components, and mechanical fixation features.
• Review medical education documentation, and live or recorded surgical procedures to better understand the critical anatomy and design features required for each project.
• Assist with the testing of designed models in mock surgical settings using equipment and tools typical of an orthopedic surgeon.
• Produce well documented steps highlighting creation, development, and execution of 3D anatomy and anatomical CAD models.
• Work with Department Managers, 3D Animators, Product Managers, Orthopedic Research and Medical Education.
• Interact with surgeons and/or clinical specialists to develop accurate and representative anatomical models and features.
• Design, participate, and when required, execute research studies involving anatomical data in either digital or physical form for anatomical or biomechanical analysis.
• Research and utilize various materials including polymeric materials such as silicone, urethane, etc. for replication of anatomical structures.
• Observe surgical demonstrations including cadaver dissections.
• Support Product Development activities related to manufacturing and production handled at Arthrex.
• Maintain an organized workflow and collaborate with team timelines and expectations.
• Attend conferences, meetings, or other educational activities to further assess new technologies and methods.
• Up to 25% travel required.

Engineer I – Product Development, ADI

• Responsible for providing technical consulting to operations and engineering teams.
• Programming new equipment and building solutions that can be deployed in manufacturing spaces.
• Establish, maintain, and enforce governance of technology.
• Create and maintain programming, hardware, and software standards.
• Develop and support training standards for engineering and technical staff.
• Maintain a portfolio of solutions for scalable deployments that support process, safety, and ergonomic improvements.
• Participates in gathering user/customer functional requirements.
• Familiar with machine protocols MTConnect, OPC UA, Modbus, MQTT, TCP/IP, and other similar protocols.
• Analyze business process potentials for streamlining and improvements in efficiencies.
• Develop Automation Design Specifications, Test and Acceptance Plans, Software testing and code review.
• Provide and support process validation procedures and execution.
• Ensure validations are compliant with appropriate regulations, such as ISO CFR 21 Part 11, 820 and cGMP regulations, and corporate policy.
• Maintain current with ISO/FDA and internal quality assurance policies.
• Develop/estimate project schedules/tasks based on requirements.
• Programming using a variety of languages for controlling and monitoring manufacturing and inspection equipment.
• Assess the impact of system changes thru change management and change control systems and develop risk mitigation and contingency plans.
• Software and hardware architectural design for the manufacturing and inspection equipment.
• Frequent use and general knowledge of industry practices, techniques, and standards.
• General application of concepts and principles.
• Lead design for all aspects of automation solution development and architecture to provide value to customers, where applicable.
• Demonstrate excellent communication skills with technical and non-technical teammates and show a high level of professionalism.
• Work effectively with all members of a cross functional software development team.
• Mentorship of lower-level engineers.
• Experience in building APIs for both internal and external products.
• Monitor equipment for abnormalities and propose areas for improvement regarding availability and speed of the applications.
• Collaborate with other engineer and technical teams to establish best practices and patterns that support high quality, reliable solutions.
• Able to travel up to 25%.

Senior Automation, SCADA Engineer

Administration

• Professionally answer incoming phone calls and respond to emails from Agency offices and their personnel.
• Support Agency personnel by providing special reports, processing returns requests and other various transactions in a timely manner.
• Communicate and collaborate with Product managers, Regional Managers & Directors in resolving issues related to special billing requirements outside of the standard Arthrex pricing structure.
• Process manual issue orders as required, including in depth research related to Synergy and Capital Equipment Issue Orders.
• Processes Issue Orders related to transitioned Agencies and provide reports to Field Audit team to have exiting agency consignment inventory removed.
• Assist AR in Processing consignment and serialized item related credits.
• Analyze all no charge issue orders to ensure that they have proper approvals and that proper promo codes are applied.
• Review all Issue Orders that are received for manual entry to ensure they have proper approvals for pricing anomalies.
• Process daily Agency Instrument Credit Report.
• Run daily VD Block Report.
• Investigate daily PGI Report.
• Process monthly reports, including PRO Code Agency billings and monthly Agency Freight Credit transactions.
• Analyze processes and collaborate with team to identify opportunities for improvements and efficiencies.
• Identify and report any non-compliant incidents to Agency Billing Supervisor or ABS/CSLR Manager.
• Ensure Arthrex procedures and policies are being followed according to Arthrex Quality Management requirements.

Agency Billing Services Administrator I

• Act as a sales consultant to surgeons
• Drive customer satisfaction and loyalty
• Collaborate with marketing team for product launches

Consultor de Ventas – Directa

• Responsible for working with Design and Manufacturing Engineering to prevent quality discrepancies and help determine the root cause and drive corrective action with the guidance of Quality Engineers.
• This would include review of DHR, inspection, functional testing, and writing an evaluation report.
• Executes such activities concerned with development, application, and maintenance of quality standards for industrial processes, materials, and products.
• Initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as chemical, electrical, or mechanical.
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Executes established programs to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.
• Executes developed methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility.
• Compiles and writes training material and conducts training sessions on quality control activities.
• May help in areas of Quality Control, Manufacturing Engineering, Metrology Process Control, Product evaluation such as customer complaints, Research and Development, and Receiving Inspection.

Engineer I – QA Manufacturing

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.

Senior Specialist, Regulatory Affairs

Customer Support

• Professionally handles incoming phone calls and processes customer orders through Esker and SAP.
• Meets productivity requirements. Aligns with department goals for accurate order processing to include communicating any customer information requiring updating.
• Communicates with leads and shipping department any pertinent issues or requests to ensure timely shipping.
• Thoroughly and efficiently gathers information for our Accounts Receivable department for orders over $50,000. Follows through to include tracking order until shipment is confirmed.
• Responsible for proper identification of order confirmation information, either fax or email, to customers through SAP order management. This includes informing customers of backorders and all other pertinent order details.
• Confirms and processes promotional orders as requested by Arthrex Technology Consultants.
• Discrepancies must be corrected and updated by contacting the customer.
• Properly handles and troubleshoots all calls providing first contact resolution. The calls should be completed with the customers’ needs met either by the customer service coordinator, assistance from Supervisor or transferred to the proper department.
• Processes email inquiries on a timely and accurate basis, researching information as required.
• Provides Agency office personnel and Arthrex Technology Consultants with customer support as needed to include Business Portal quotes, office forms, orders or any information requested.
• Responsible for checking open order, incomplete and back-order reports through SAP multiple times daily. This includes follow up with Account Receivable for any orders on AR block and resolution of any other block that prevents the order from on time shipping. All orders should be corrected and released within 5 days and if not reconciled, either line or order rejected.
• Required to work flexible hours as needed by department to include mandatory month end until 7 PM or upon completion of all orders submitted. Required to work extended hours during fiscal year end to ensure all orders are processed and shipped on time.