Cook Group

Software Engineer

• Utilize engineering knowledge to produce project deliverables / documents
• Adhere to the Quality Management System (QMS) and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective communication skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations

R&D Engineering Co-op

Compliance

• Communicate and interface directly with regulatory authorities to ensure product approvals are achieved in a timely manner, if needed.
• Communicate Country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assist with the regulatory strategies.
• Obtain and maintain product approval, and serve as a communication liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor.
• Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions.
• Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.
• Perform translation activities.
• Provide support to currently marketed products as necessary including input on change requests, etc.
• Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies.
• Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data.
• Provide support to currently marketed products as necessary including input on change requests, etc.
• Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Regulatory Affairs Specialist

• Engineering CO-OPs may be involved in projects in the following areas: Equipment Application; Device Development; Manufacturing Support; New Technology Support and Development/ Process Control; Process Validation; Product Development; Quality Engineering; Project Engineering; Systems Support: Research and Technical Writing.
• Produce engineering deliverables/documents; Provide analysis of recommended solutions to any obstacles or problems during production.
• CO-OPs are assigned a direct mentor who provides a unique perspective of life at Cook.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

Co-op – Research and Development Engineering

Human Resources

• Partners across functions to deliver value-added service to leadership and employees that reflects the business objectives of the organization, developing strategic relationships with internal and external stakeholders
• Supports employees on human resource matters or queries they may have and facilitates actions to resolve these in a timely manner
• Builds strong relationships based on trust with employees and leaders throughout their customer teams
• Partners with Business Leaders in developing team plans to support the business strategy
• Coaches and empowers leaders during the entire employee life cycle, regarding HR matters/challenges and facilitates effective and proactive decision-making to ensure solutions are realistic, fair, timely, consistent, transparent and effective
• Provides input in design and development of company-wide HR initiatives and programs to ensure alignment with business requirements
• Leads HR Functional Projects
• Manages and resolves complex employee relations matters. Conducts effective, thorough and objective investigations where required
• Assists in developing, implementing and administrating HR policies/procedures, ensuring compliance with relevant statutory legislation and industry best practice
• Trains and mentors HR Generalists as required
• Collaborates with other HR team members locally and across the organization globally
• Collects and analyses employment data for recommendations to the management team, maintaining records as needed and providing HR Leadership with new HR strategy proposals
• May manage the entire recruitment and selection process in line with business needs, continually looking to introduce improvements where possible
• Provides day-to-day performance management guidance to leadership (e.g., coaching, counseling, career development, disciplinary actions)
• Provides guidance and input on business unit restructures, workforce planning and succession planning

Human Resources Business Partner

Research Analyst

• Stakeholder collaboration: Partners with stakeholders to understand business strategies and research needs. Maintains strong business acumen and a deep understanding of the market. Facilitates meetings to discuss research objectives, plans, project status updates, deliver insights, and foster collaboration. Works closely with external partners to support recruitment and research needs.
• Project management: Prepares and executes large, complex, strategic project plans that align with business goals and research objectives, including secondary data sources, research methodologies, timelines, and cost estimates. Monitors progress and communicates project status updates to stakeholders.
• Data collection and analysis: Designs and administers qualitative and quantitative primary research, including web-based surveys, focus groups, and in-depth interviews. Prepares discussion guides and survey instruments. Collects data on the market, customers, employees, and competitors to develop a comprehensive understanding of internal and external business conditions. Analyzes data using statistical techniques and software tools.
• Reporting and presentations: Translates complex data into clear, easily interpretable, and engaging insights. Creates reports and presentations of research findings by summarizing key insights, providing detailed findings, and generating recommendations for action. Presents insights in a storytelling format. Collaborates with key stakeholders at different levels across the organization to interpret results and ensure insights are understood and used effectively.
• Continuous improvement: Continuously evaluates and improves the process for generating insights that are relevant, timely, and actionable. Maintains quality standards and best practices; remains current on best practices, methodologies, techniques, and technology within the rapidly growing field of research and analytics. Identifies and recommends external research partners.
• Mentorship and team leadership: Provides guidance and mentoring to junior market research analysts, helping to develop their research and analytical skills. Trains team members on processes for generating and delivering insights .

Senior Research Analyst

Architect

• Ensuring strong semantic modeling, data design, and governance practices.
• Establish standards, processes, and operating models for consistent ontology creation, maintenance, and evolution.
• Serve as the primary decision-maker for semantic definitions, conceptual models, and enterprise vocabulary management.
• Oversee the design and maintenance of ontologies that accurately represent business concepts, relationships, hierarchies, and constraints.
• Partner with domain experts to ensure semantic models reflect real business processes and data usage patterns.
• Guide the extension of ontologies to support new product lines, operational processes, or regulatory needs.
• Lead the creation and management of semantic models within Microsoft Fabric IQ, including domain modeling, semantic enrichment, and unified business definitions.
• Oversee the design and governance of Palantir Ontology artifacts, including object types, relationships, functions, schema transformations, and operational pipelines.
• Define the enterprise semantic architecture, including how ontologies integrate with data products, data pipelines, APIs, and AI/ML solutions.
• Enable AI and ML teams by providing well-structured, semantically rich data environments.
• Collaborate on the development of AI agents and semantic reasoning features that depend on precise data meaning.
• Partner with product teams, business stakeholders, data stewards, engineers, and analytics teams to ensure trusted data meaning across the enterprise.

Ontology and Semantic Architect

QA Engineer

• Adhere to CRI Quality Management System (QMS) procedures and applicable regulatory requirements.
• Provide support to QA team members as needed, responding to requests in a timely and professional manner.
• Quickly develop an understanding of assigned projects, including terminology, objectives, and quality requirements.
• Collaborate with a mentor and other QA team members to define tasks, prioritize responsibilities, and deliver work on time and to expected quality standards.
• Complete required documentation accurately, clearly, and within established timelines.

Quality Assurance Intern

Business Operations

• Own the implementation and continuous improvement of operational processes for the AI/Innovation group.
• Execute and follow up on operational activities in alignment with global and regional objectives.
• Drive consistency in priorities, processes, and programs across the AI/Innovation group.
• Serve as the primary liaison between the AI/Innovation group and other departments.
• Facilitate knowledge sharing and effective collaboration across team members and stakeholders.

Manager, Business Operations – Execution

Program Manager

• Provide a single point of contact for all aspects of the assigned programs and projects, interacting as necessary with team members and stakeholders at all levels of management.
• Work with key stakeholders in the divisions, entities and functions to define full program scope and lead the operational planning for assigned the projects at a program level.
• Establish meeting agendas, facilitate team discussions, and drive clear and timely team actions and decisions.
• Multi-project coordination.
• Pro-actively addresses barriers and risks to program progress, keeping leadership informed of critical considerations.
• Lead and facilitate team discussion and documentation of new information, including pros, cons, and risks.
• Ensure that program deliverables are achieved on or ahead of schedule, within budget, and with quality that meets or exceeds business needs.
• Work with project teams and leadership to aggregate and synthesize program KPIs and organizational metrics.
• Manages scheduled and ad-hoc program status reporting
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Expert in listening and understanding what motivates team members and stakeholders to establish and maintain engagement and support.
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations.

IT Support

• Lead enterprise AI/ML initiatives including natural language processing, computer vision, and predictive analytics implementations that generate substantial business value through process automation, enhanced customer insights, and operational optimization across the organization
• Lead AI innovation efforts, identifying emerging technologies that can enhance products or operations
• Design and manage modern Data, ML and AI platforms leading a culture of Data as a Products and AI data ready strategy
• Establish innovation centers focused on evaluating and piloting emerging technologies including quantum computing, blockchain, augmented reality (AR/VR), and IoT solutions
• Design and implement modern digital platforms using API-first architectures, event-driven systems, and cloud-native technologies that support omnichannel customer experiences
• Define and execute the company’s technology enterprise architecture, technology roadmap, and strategy in alignment with business goals
• Oversee software development, software delivery, and modern applications development methods
• Define and execute platforms seamless integration strategy and ruthless systems standardization
• Conduct comprehensive technology landscape assessments leveraging Gartner Hype Cycles, Forrester Wave reports, and industry benchmarking
• Build and mentor high-performing tech teams, fostering a culture of innovation and accountability
• Manage budgets and KPIs for technology initiatives and ensure ROI on tech investments
• Develop and manage systems, metrics, and internal training activities needed to support objectives
• Collaborate, negotiate and influence other executives, staff, board members, and external parties on behalf of Cook, Divisions, Functions, Entities, etc.
• Manage and safeguard all Cook Medical intellectual property
• Ensure that all aspects of the organization operate holistically in support of objectives as stated in our Annual Business Plan and in compliance with the Cook Group Code of Conduct and written standards.

Senior Director, Global IT Enterprise Architecture, Applications

Project Manager

• Work with key stakeholders to define full project scope and lead the planning for assigned projects.
• Establish meeting agendas, facilitate team discussions, and drive clear and timely team actions and decisions.
• Pro-actively addresses barriers and risks to project progress, keeping leadership informed of critical considerations and the implications of priority decisions.
• Ensure that project deliverables are achieved on or ahead of schedule, within budget, and with quality that meets or exceeds business needs.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Manages scheduled and ad-hoc project status reporting.
• Manage project communication for all entity stakeholders, including providing leadership updates.
• Lead and facilitate conversations between functions when there is new information, including scope changes, risks, and competing priorities.
• Expert in listening and understanding what motivates team members and stakeholders to establish and maintain engagement and support.
• Must maintain company quality and quantity standards.

Project Manager, Research and Development

Manager

• Collaborate with key stakeholders to establish, measure, and meet business plan goals for assigned specialty and geography.
• Support accelerating market adoption for the assigned specialty.
• Provides product & market support.
• Responsible for being the regional product champion/expert.
• Collaborate with key stakeholders to ensure consistent messaging for the assigned specialty.
• Support conversions with key customers for the assigned specialty.
• Answers sales & customer questions for the assigned specialty.
• Support product launch, campaign planning & execution.
• Provide consistent program-related field communications.
• Present launch content to sales & support internal sales meetings.
• Collaborate on sales tools and messaging needs.
• Create market updates to send to the field.
• Responsible for customization of large accounts.
• Responsible for actively engaging CRM as a key tool for communication & sharing customer & market insights back into the organization.
• Initiate focus campaigns in cooperation with sales.

Market Development Manager

Marketing

• Contributes to the development of strategic objectives for marketing projects and campaigns
• Collaborates with the agency to initiate projects and develop project plans for marketing campaigns and content
• Understands the audience and objective of marketing projects to help identity appropriate reviewers and collaborators
• Performs desktop research on markets and competitors
• Manages marketing channels with limited supervision, working closely with events and digital marketing teams
• Assists marketing managers with marketing planning duties or projects, as assigned
• Engages with sales team through CRM and other communication methods to support launch of marketing tools and gain feedback
• Collaborates with digital marketing team, to analyze campaign data and provide reports to marketing managers
• May support more than one specialty
• Works independently with limited supervision on larger, moderately complex projects
• Uses prior experience, analysis, and a broad understanding to find solutions to difficult, and sometimes, complex issues
• Foster and maintain a workplace culture respectful and supportive of individual differences
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must maintain company values, policies and standards
• Must have effective oral and written communication skills

Marketing Specialist

• Prepare Medical Device Files for submission to regulatory authorities, with a focus on European Notified Bodies
• Maintain Medial Device Files and other regulatory documentation
• Maintain regulatory license databases and systems which contain regulatory approval or restriction information
• Liaise with relevant departments at Cook Australia and at other Cook sites, as necessary, to understand and collate information required for regulatory submissions
• Communicate with regulatory agencies and conformity assessment bodies
• Provide regulatory support to engineering projects, as necessary
• Review global marketing materials for compliance to relevant advertising guidelines
• Perform administrative tasks, including document formatting, and preparing documentation for the internal change control process.

Regulatory Affairs Specialist – 12 Month Fixed Term Contract

• Direct and maintain a scalable, global structure for post market quality assurance ensuring clear communication and alignment with regional regulatory needs and business objectives.
• Develop and lead strategic vision and objectives for the global post market quality assurance team, ensuring alignment with overall corporate goals, regulatory requirements, and operational excellence initiatives.
• Collaborate closely with global functional leadership to ensure local market needs are integrated into global strategies.
• Provide leadership and mentorship and technical expertise to a diverse geographically dispersed post market quality assurance team, ensuring alignment with global standards and regional needs.
• Oversee and manage post market quality assurance budgets, including cost tracking, and strategic planning to support global operational priorities.
• Oversee and ensure that all post market quality activities comply with applicable regulations, including but not limited to: ISO13485, US FDA CFR Part 820, State Council Order No. 739- China, PMD Act, Law Act 145- Japan, Medical Device Management Act- Taiwan, Medical Devices Act- Korea, Good Distribution Practices-Thailand, etc. Proactively monitor regulatory changes and lead updates to post market quality assurance to maintain compliance.
• Drive adherence to relevant Quality Management Systems and Business Processes, promoting a culture of quality and organizational effectiveness.
• Engage effectively with stakeholders across all levels of the global organization, including regional regulatory agencies, to foster strategic relationships, influence policy, and ensure compliance. Lead cross-functional collaboration to optimize post market quality assurance processes.
• Foster a high-performance culture focused on talent development, succession planning, and continuous improvement.
• Establish and maintain global best practices, standardised policies, and/or procedural controls as needed to ensure consistency, accuracy and compliance of PMQA work outputs and systems. Balance standardization with regional flexibility where necessary.
• Champion a continuous improvement culture by leading initiatives that leverage AI and digital tools, automation, and innovate processes to enhance efficiency, accuracy and compliance in PMQA activities.
• Ensure local and corporate entities fulfil PMQA economic operator roles and responsibilities, including those for in-country representatives.
• Oversee the health of the PMQA QMS through proactive data collection, trend analysis, and implementation of improvement actions.
• Direct leadership to ensure compliance of the PMQA QMS with global QA policies, procedures, and direction.
• Oversee customer complaints, recall, and adverse reporting processes, ensuring appropriate handling, escalation, and resolution by relevant teams.
• Serve as the Global Process Owner and represent Cook during internal and external audits.
• Represent PMQA globally, participating in working groups and supporting the voice of Cook and patients in industry guidance and regulation commentary.
• Ensure post market quality assurance team members possess the requisite technical skills, experience, and training to perform their work.
• Provide strategic recommendations for workforce planning and contribute significantly to employee related decisions and development initiatives.
• Foster and maintain a positive, inclusive and productive work environment aligned with Cook’s culture and values.
• Maintain overall accountability for PMQA QMS performance, communicating effectiveness and improvement needs to executive management and ensuring timely corrective actions.