Artex Risk Solutions

Product Manager

• Plans, organizes, and controls an assigned product line from conceptual stages through product life cycles to optimize profit and meet marketing, financial, and corporate growth objectives
• Develops new products in conjunction with Marketing, Engineering and Sales Management personnel
• Manages day to day progress of product
• Participates in overall product strategy, research and development requirements, development, and manufacturing coordination for new and emerging products
• Coordinates technical product development, estimates of potential profits, and release to production specific to product line
• Collaborates with a wide variety of functional areas such as sales, engineering, marketing, manufacturing, and operations to develop and provide product definitions responsive to customer needs and market opportunities
• Provides technical expertise and training to other departments in support of product development
• Conducts marketing analysis to develop product definitions
• Develops and maintains a prioritized list of customer and market requirements for product
• Coordinates and develops marketing, sales, engineering, and financial plans for product line
• Provides financial and technical justification for product selection and definition
• Prepares product development objectives and schedules for all phases of product development and introduction to market
• Conducts market research and identifies and tracks market trends in company's industry
• Produces competitive analysis materials comparing product with its key competitors
• Identifies partnering opportunities for complementary third-party products to broaden company's product line
• Participates in key sales situations for the product
• Maintains communications and contacts to collect and analyze technical, financial, schedule, and sales information for product line
• Identifies market potential, establishes pricing and market strategies, estimates potential sales, introduces market, distribution/channel issues, and manages mature product through phase-out
• Provides expertise in particular product area and develops strategies and applicable portions of the company business plan
• Plans, organizes, and coordinates assigned programs to ensure accomplishment of financial/budgetary goals and optimum allocation of resources
• Manages resources to execute assigned programs
• Coordinates details of program within the organization with a wide range of functions and individuals
• Coordinates product introduction and market exploitation with marketing and sales organizations to ensure maximum penetration of market segment
• Provides continuing product surveillance and management of established product to obtain financial objectives
• Responsible for tracking product development through the development process from product concept, design, prototype to actual release by resolving issues that arise
• Drives and champions development requirements and ensures that project risk is minimized
• Submits reports and status updates to senior management
• Determines the initial production quantities and twelve month moving forecast
• Acts as the primary interface with assigned customers and its agents for all matters
• Responsible for maintaining communication with the customer to maintain and control project scope as applies to defined design, budget, quality and schedule agreements
• Provide technical assistance with complex customer issues as well as consulting services to streamline customer internal management processes
• Confers with project staff to outline/negotiate work plans, assign duties and responsibilities, determine schedules and define scope of authority
• Reviews/analyzes status reports prepared by the project team personnel and modifies schedules and/or plans as required
• Monitors financial activities to ensure team compliance to budget parameters
• Establishes project plans, scope of work and accompanying definitions
• Prepares technical and financial reviews of the assigned projects and presents information to Senior Managers, business unit management, customer and project team personnel as required
• Prioritize staff workloads in order to meet customer needs/objectives in all areas
• Develop and train staff to ensure high skill levels
• Assigns and monitors program staff, providing technical support and direction
• Establishes operational and project objectives and assignments and delegates assignments to project team
• Directs and coordinates the activities of project team personnel (engineering, manufacturing, procurement, marketing and quality) to ensure projects progress on schedule and within prescribed budget
• Performs market analysis, product strategy and research and development
• Conducts surgeon and sales rep product and procedure training
• Collaborates with a wide variety of functional areas such as sales, engineering, marketing, manufacturing, and operations to develop and provide product definitions responsive to customer needs and market opportunities
• Manages the development stage of the product life cycle
• Responsible for ensuring that all customer requirements are met including the monitoring of test reports, documentation of instructions, etc.
• Defines promotional activities, publicizing the product through the press, sales force, and alternate distribution channels
• Establish and maintain relationships with key surgeons.

Product Manager, Upper Extremity

Manager

• Manage special projects (e.g., internal hotline, Chatter) and corresponding activities with accountabilities for successful completion.
• Educate and train Arthrex’ Sales team and respective agencies, as assigned, on all aspects of U.S. reimbursement (coding, coverage, payment, and contracting) for the product portfolio and messaging in-person, virtual meetings and on-demand phone calls.
• Develop, manage, and deliver reimbursement educational programs for Arthrex internal (sales reps. & sales leadership) and external (surgeons, hospitals, ASCs, payers) customers.
• Collaborate with Marketing, Sales, Product Management and Regulatory teams to anticipate market needs and inform the development of customer-facing tools, economic models, and other tactical elements of reimbursement to maximize patient access to Arthrex’s technologies and products.
• Work in partnership with Sales and Sales leadership to plan and prioritize key customer visits, virtual and in-person, to provide education, and deliver value-based messages to drive patient access.
• Develop and implement reimbursement, market access, and value-based strategies to promote broader access for patients, in alignment with commercial objectives.
• Develop and support relationships with local physician champions to support interactions with payors.
• Monitor and research reimbursement trends, market changes, coverage issues, coding developments, payment methodologies and communicate recommendations.
• Triage and manage routine internal and external requests.
• Travel up to 40%.
• Ensure compliance within functional areas and support the compliance objectives of the organization as a whole.

Manager, Market Access and Reimbursement

Support Engineer

• Plan, organize, schedule and supervise the day-to-day Technical Assistance Center operations in assigned area of responsibility.
• Lead, manage, develop, train and review performance of staff.
• Provide timely reporting to Arthrex Leadership regarding the overall performance of the Technical Support Representative Team.
• Establish appropriate individual goals per the Key Performance Indicators of the Global Service & Repair organization.
• Measure and maintain customer satisfaction.
• Ensure all team member issues and concerns are addressed in a timely manner, encourage involvement from all team members and foster a positive team environment.
• Manage and schedule training and development for team.
• Develop and maintain department policies, procedures, and processes.
• Collaborate with other Arthrex departments such as Sales, Product Surveillance, and Product Management to ensure escalated customer requests are resolved to the customer’s satisfaction.
• Identify and implement process improvements that enhance customer experience and /or meet future business needs.
• Deliver annual Performance Reviews and maintain records of their team.
• Work in partnership with Technical Support manager in hiring decisions.
• Required to work flexible hours as needed to support customer needs.

Technical Support Supervisor

Data Scientist

• Act as the primary liaison for data management deliverables on assigned studies.
• Provide senior-level guidance and support to the Data Managers team across multiple large-scale studies.
• Supervise the preparation of data collection forms, database design, specification and testing, cleaning, locking, extracting, and reporting on study progress for internal and external stakeholders.
• Collaborate with clinical research, data managers, and other internal teams, focusing on continuous process enhancement, issue resolution, workload forecasting, and technical consultation.
• Participate in data management strategies for regulatory and marketing initiatives.
• Lead data management efforts for internal and outsourced studies.
• May manage staff responsible for performing those activities.
• Lead data management activities, including creation of data management plans and data review plans (DMP & DRP), as well as training materials.
• Lead development and review of SOPs, work instructions, and associated documents for CDM.
• Creates and enforces processes for effective database build and data management in EDC, CTMS, ePRO and eTMF systems.
• Support the development of study-specific database builds using study protocol and configuration specifications.
• Is compliant with project and data management plans for data handling and sharing with the clinical research team.
• Oversees/Performs User Acceptance Testing (UAT).
• Support the clinical research team and sites in the daily use of data systems and ensures adherence to legal and company standards.
• Facilitate stakeholder training of data management systems.
• Lead manual listing review activities according to the DMP and DRP.
• Manage ongoing query review with closures of system-generated queries according to the DMP and DRP.
• Lead the distribution of data reports, extracts, and other deliverables as defined in the data management plan.
• Conduct data management meetings and provide clinical team updates regarding data listings, issues, cleaning, and locking.
• Lead and coordinate the creation of study-specific eCRF Completion Guidelines.
• Assures databases and archives are protected from security breaches and losses.
• Manage troubleshooting activities for data-related problems.
• Manage clinical data cleaning and delivery activities, including database lock.

Senior Clinical Data Manager

Clinical Research

• Initiate clinical research for Arthrex-sponsored studies
• Planning, executing, managing, and oversight of clinical studies
• Leads the implementation of clinical protocols, informed consent forms, and study-related materials for clinical studies
• Manages site initiation activities (e.g., study start-up documentation preparation)
• Responsible for IRB communication, including document preparation and submission of Arthrex study initiatives.
• Implementing modifications to optimize protocol results or edit/amend study documentation if necessary
• Assists with ensuring the electronic data capture system (EDC) is designed to collect all required data per the protocol
• Responsible for training internal staff assigned to studies
• Maintain appropriate monitoring and maintenance of clinical sites to ensure the overall successful conduct of assigned clinical studies
• Oversee all aspects of the assigned clinical projects, including essential documents, electronic data collection, change management, risk management, and monitoring activities
• Set-up and maintain accurate progress and Site study status tracking logs to provide reports and updates of assigned clinical research projects
• Oversee follow-up and lead query resolution with sites via ongoing interactions
• Participation in investigator meetings, Site initiation, monitoring, and close-out visits when applicable
• Complete central, remote, and on-site monitoring reports and follow-up letters
• Complete monitoring report reviews of other staff
• Oversee monitoring activities for the assigned projects and is responsible for ensuring actions are taken when applicable
• Identify and mitigate quality risk and/or issues associated with assigned studies/activities
• Facilitate appropriate documentation to maintain compliance with the Finance and Compliance departments
• Prepare and track clinical study budgets
• Responsible for the timely completion of deliverables, inclusive of analysis of large data sets/spreadsheets using Excel or other applications for interim study status reporting to meet Arthrex and research goals
• Facilitate efficient utilization of available clinical data, addressing the needs of internal and external stakeholders (e.g., publications)
• Works closely with leadership, product management, medical writing, project manager, and other research staff to manage assigned studies
• Execute clinical studies according to ICH/GCP guidelines, ISO guidelines, and internal SOPs

Senior Clinical Study Manager

• Manage and support global Arthrex Health Care Professional (HCP) engagement: including supporting the global needs assessment, consultant selection and engagement, fair market value (FMV) analysis, and consultant compensation/reimbursement.
• Lead the HCP Engagement teams responsible for managing Arthrex’s overall HCP consultant engagement processes to ensure compliance.
• Lead, manage and coordinate processes related to the HCP Needs Assessment process, including coordination with business units to determine and present annual need for HCP consultant services and individual HCP engagement.
• Support and manage overall processes related to HCP interactions and work on related continuous improvement projects.
• Work closely with other internal business units to support overall management of the HCP consulting relationships.
• Manage fair market value assessment for global HCP consultant engagement.
• Maintain and enhance the process for tracking of all consulting services provided under the business units Needs Assessment as well as any modifications.
• Manage the HCP due diligence process to include communication with internal business and HCP consultant; collect, review, and verify required documentation and screening requirements.
• Collect, review, and verify payment documentation, and approve consultant electronic invoices and expense reports for HCP consultants.
• Facilitate issue resolution related to contracts and payments in a timely manner.
• Train HCP consultants and employees on systems and processes to ensure compliant interactions.
• Develop and manage implementation of policies, procedures and processes related to HCP engagement processes.
• Coordinate with Compliance Auditing & Monitoring functions to provide periodic Arthrex HCP engagement data analysis, including comparison of needs assessment data to actual use, reviewing issues with relevant business units, and working with Arthrex internal and external personnel to resolve identified issues.
• Support global transparency reporting processes and initiatives as needed.
• Support activities and initiatives of the Risk Management & Compliance Department as needed.
• Ensure compliance within functional area and support the compliance objective of the organization as a whole.

Manager, HCP Engagement

Full-stack Engineer

• Responsible for full life cycle development of medical devices: initiation, design, development, execution, and product maintenance
• Design components or functional systems and modify existing designs to develop or improve products and facilitate manufacturing
• Recommend alterations to development and design to improve quality of products and/or procedures
• Determine budgets and timelines for assigned projects and report progress/status in a timely basis
• Lead multifunctional new product project teams through technical feasibility analysis, initiation, planning, execution, and termination
• Maintain design history file for assigned projects adhering to Arthrex design control procedures
• Provide Regulatory department technical support and support Marketing/Product Management with technical information
• Support Manufacturing for processing improvements and support surgeon and distributor customers via training/education
• Determine necessity of testing and initiate testing of assigned products
• May be required to travel to trade shows, visit accounts, and international travel may be required

Principal Engineer - Product Development - I&R

Analyst

• Manage technical and non-technical administration and maintenance of Arthrex’s global LMS
• Support users, provide technical support, troubleshoot employee, training, and system issues
• Create, upload, organize, and maintain training content, courses, and learning materials
• Create course registrations and track attendance; monitor training completion and learning metrics
• Generate routine and ad hoc learning reports for internal stakeholders
• Partner with departments to create and deliver online and instructor-led training and curricula
• Support LMS-related Quality Management System (QMS) training and ensure compliance with legal and company standards
• Support digital learning and organizational development applications and other L&D projects
• Create system guides and documentation; assist with learning team email inbox and related tools

Associate LMS Analyst

QA Engineer

• Responsible for Quality Assurance functions and design development activities of Class I and II medical devices in compliance with FDA, ISO, CMDR Quality Systems and Design Control requirements.
• Lead design assurance efforts within product design and development for new product introduction projects with emphasis on software, electrical, and/or mechanical device characteristics.
• For electrical/active device projects, lead compliance for electrical safety, environmental, and emissions per national and international regulations.
• Ensure appropriateness of documented design requirements and outputs and maintain traceability throughout product development lifecycle.
• Provide leadership implementing regulations/standards and act as resource to other disciplines from idealization through product retirement.
• Supervise, assign, and coordinate work of others within the design assurance team to support department and project goals.
• Lead lessons learned initiatives to improve design processes and the quality management system.
• Lead product risk assessment activities using ISO14971, FMEAs, FTA, and Hazard Assessment.
• Provide guidance on usability/human factors engineering principles (IEC 62366) and FDA guidance for compliance.
• Facilitate planning, execution, and review of verification/validation activities including assessment of inputs to the v&v process.
• Lead design assurance aspects of Design to Manufacture Transfer, including inspection methods, drawing reviews, KPIs, and manufacturing training.
• Ensure required outputs of design control are met, maintain Design History File (DHF), and support transition to sustaining engineering.
• Support design-related corrective and preventative activities and establish/maintain Risk Management File(s).

Senior Engineer I – QA Design

• Arthrex is a global medical device company and leader in new product development and medical education in orthopedics
• Software Engineers design, develop, test, and maintain high-quality software to meet business and customer needs
• Develop features and capabilities for end users and configure/customize vendor-provided packaged software
• Sr. SAP Integration developer and technical thought leader: lead projects using SAP PO and Cloud integration tools throughout complete lifecycle
• Architect and build application integration solutions and understand integration patterns and best practices for creating integration ABAP objects
• Analyze ABAP code objects, complex business processes, and create technical requirements and specifications for SAP work streams
• Configure SAP Web Services and ALE distribution models and lead offshore development teams
• Prepare technical documentation, participate in production support, and adhere to Quality System Procedure and Change Control
• Lead design for full stack development, mentor lower-level engineers, implement CI/CD improvements, and monitor applications for availability and performance improvements

Senior Software Developer, SAP PO

MAIN OBJECTIVE: Works with Regional Director to: Ensure maximized revenue growth of assigned company products and services through direct and indirect management of an independent sales force in a defined geographic product area. Establish proper and effective communications with appropriate staff across the company to ensure the proper level of sensitivity to the needs of sales. ESSENTIAL DUTIES AND RESPONSIBILITIES: Works within an assigned geographic sales and product area to maximize sales revenues and meet corporate objectives: Carries out specific plans developed by the Regional Director and company to ensure revenue growth in company’s products. Manages assigned account activities. Communicates regular field activity to President, SVP of Sales, Regional Director, and other internal management. Completes LMS self-education requirements. Develops independent sales team (agency): Monitors and assists in the activities of agency (product training, coaching representatives, TC program, motivates, recommends representative additions and termination as necessary, etc.). Educates sales team in terms of sales tactics. Recommends sales programs and training ideas to Regional Director and SVP Sales to address the following issues: New and existing account sales growth. Sales of new and existing products and multi-product sales. Competitive strategies and targeted sales campaigns. Proper use and level of sales support. Account and Third-party contracts. Performs sales activities on accounts and negotiates product pricing discounts pre-approved by the Regional Director and SVP of Sales. This job requires that a person must travel 3+ days out of the week and occasionally work on weekends.

Regional Manager, Sports Medicine

Business Development Rep

• Set business development strategy and asset deployment for agency Cardiothoracic business. Follow up with agencies frequently to ensure strategy is being executed. When needed identify weaknesses and offer evidence-based solutions.
• Serve as a resource to agencies to maximize growth and competency of product line.
• Launch Cardiothoracic new products within region. Re-launch when necessary.
• Govern Cardiothoracic product pricing structure and qualifying discounts as they relate to volume and commitment levels. Heavy intervention is required here due to the strategic nature of the Cardiothoracic product line. Working with local, regional and national buying groups is essential.
• Assisting representatives with evaluation and closing activities with key customers and collaborating with agencies on representative sales readiness as it relates to Cardiothoracic.
• Training representatives on Cardiothoracic products and sales cycle as needed.
• Communicating agency focus and structure as it relates to Cardiothoracic to Director of Global Cardiothoracic Business Development, Senior RM and SVP Sales.
• Communicating product attributes and shortcomings to product managers and recommending product line enhancements.
• Collecting key competitive information and ensuring that knowledge drives both sales effectiveness and product development direction.
• Coaching, teaching, and when necessary, directing Cardiothoracic team via conference calls and in person visits on products/sales strategy/competitive info.
• Engage current and identify new Key Opinion Leaders for Local, Regional, and National peer to peer interactions.
• Lead or assist on 2-3 projects every 6 months.
• Up to 75% travel.

Job title: Business Development Manager - Cardiothoracic- West

• Oversees Spine product sales performance, training, and activities with sales force, surgeons, and accounts in region
• Implements sales strategy for agency Spine business; follows up with agencies; identifies weaknesses; offers evidence-based solutions
• Ensures agencies are structured to maximize growth; assists with recruitment; deploys Arthrex training programs
• Organizes and leads agency Spine training; launches Spine new products within region
• Presents Spine products and bundled strategy at high-level meetings
• Governs Imaging & Resection product pricing and discounts
• Assists representatives with trialing and closing; reports to agencies on readiness
• Builds custom solutions to maximize opportunity and business impact
• Communicates agency focus to North American leadership; shares product performance with management; recommends enhancements
• Collects competitive information; uses insights to drive sales effectiveness and product direction
• Coaches and directs agency personnel via calls, virtual meetings, and in-person visits
• Travel up to 75%

Regional Manager-Spine-Southeast & South Atlantic Regions

• Oversee Imaging and Resection product sales performance, training, and activities within region
• Implement sales strategy for agency Imaging and Resection business
• Follow up with agencies frequently to ensure strategy is being executed
• When needed identify weaknesses and offer evidence-based solutions
• Ensure agencies are properly structured to maximize growth and competency of product line
• Assisting with recruitment of experienced capital managers and deploying Arthrex training programs
• Collaborate regularly with Arthrex Regional Management team to achieve organizational objectives across product portfolio
• Launch Imaging and Resection new products within region
• Present Synergy imaging and resection products as well as bundled strategy at high level meetings
• Communicating with high level admin and IT regarding imaging product HIPAA compliance, integration, and networking capabilities
• Govern Imaging & Resection product pricing structure and qualifying discounts as they relate to product bundling
• Assisting representatives with trialing and closing activities at key accounts and reporting back to agencies on representative sales readiness as it relates to Imaging and Resection
• Creatively building custom solutions to maximize opportunity and business impact
• Communicating agency focus and structure as it relates to imaging and resection to North American Director of Sales I&R, Regional Director, Senior Director of Sales East, and VP Sales
• Communicating product performance to product management and North American Director of Sales while recommending product line enhancements
• Collecting key competitive information and ensuring that knowledge drives both sales effectiveness and product development direction
• Coaching, teaching, and when necessary, directing agency personnel via conference calls, virtual meetings, and in person visits on products/sales strategy/competitive info
• Travel up to 75% of the time

Regional Manager- Imaging & Resection- Central Region

Medical writer

• Manage regulatory medical writing for international markets; write, edit, and review CEPs, CERs, PMCF plans, SSCPs, PMS plans, PMSRs, and PSURs in accordance with global regulatory requirements to support Arthrex’s regulatory compliance and global market sales.
• Collaborate with cross-functional teams (Regulatory, Clinical, Quality, Marketing) to ensure submission-ready clinical documentation; liaise with Project Manager and other cross-functional teams as applicable to provide input and gather required information.
• Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation; review or edit clinical regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures.
• Maintain periodic updates, perform gap analysis, and revise existing documents as necessary; participate in audits; may develop or conduct employee training.