UNKNOWN

ADAPTED_NOW

As part of project/technical leadership, responsible for leading technical development of projects; leading all key design decisions to ensure quality of design selection to meet customer needs; retrospective project reviews to understand lessons learned; managing device evaluations and compliance with Quality, Regulatory and company policies and systems; Bachelor’s degree in engineering or related field required and 7 years’ relevant experience OR; Master’s Degree and 5 years’ relevant experience OR; PhD and 4 years’ relevant experience; Experience in Product Development projects within Medical Device or regulated industry/adjacent experience.

<h2>Why Join Us</h2>We believe in taking care of our people so they can take care of others. As a global, family-owned company that has been improving patients’ lives since 1963, we’re committed to doing business with integrity and making a positive impact in the communities where we live and work. We’re guided by strong ethical standards and core values, and we believe the best ideas come from creating solutions together. Our company culture values every voice, brings together inclusive teams who collaborate well, and encourages learning and innovation. When you join Cook, you’re not just starting a job, you’re building a career with purpose, in a company that invests in you. What You Can Expect at Cook These are some ways we support our people across Cook:· Meaningful work & strong values: Contribute to improving patient care globally in a company known for high ethical standards and integrity.· Competitive rewards & security: Competitive, performance-related compensation and benefits that support your health and financial wellbeing.· Flexibility & time off: Paid time off, holidays, and hybrid or remote work options for many jobs, where possible.· Growth & development: Learning opportunities, educational assistance, and development programs to help you grow your skills and career.· Wellbeing & community: Health and wellness initiatives, social activities, and community engagement that help you feel connected and supported. Benefits and programs vary by country and job. Our recruiters can provide more information about the specific benefits and programs available in your location.<h2>Overview</h2>This role will lead a team of engineers focused on research, development, and implementation of new medical device designs. This role will be responsible for technical leadership within the project team which could include signing off on deliverables and supporting the training and delegation of work responsibilities to other engineers on the team. This role will not have direct employee responsibilities.<h2>Responsibilities</h2>Lead project teams or provide technical leadership for medium to largescale R&D projects, collaborate to provide technical leadership across the department and/or multiple projects in a specific area or subject matter expertise; Drive improvement initiatives in area of expertise, which may include process ownership for department; Responsible for approval of work product or work for project teams; Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved in collaboration with project manager (when one is assigned); Work closely to build effective relationships with cross functional groups to achieve project and company goals; As part of project/technical leadership, responsible for leading technical development of projects; leading all key design decisions to ensure quality of design selection to meet customer needs; retrospective project reviews to understand lessons learned; managing device evaluations and compliance with Quality, Regulatory and company policies and systems; May represent Cook in industry standards, working groups and present on Cooks behalf in industry conferences; and Act as a mentor to other personnel in the department.<h2>Qualifications</h2>Bachelor’s degree in engineering or related field required and 7 years’ relevant experience OR;Master’s Degree and 5 years’ relevant experience OR;PhD and 4 years’ relevant experience;Experience in Product Development projects within Medical Device or regulated industry/adjacent experienceProven project/technical leadership;Project management methodology and skills;Proven experience working closely with project managers; Knowledge of medical device quality standards ISO13485/FDA practices, EUMDR, GMP and similar regulated industry standards;This role requires fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers; andQualified candidates must be legally authorized in the United States. Cook does not intend to provide sponsorship for employment visa status’ for this employment position.

Cook Group

Lead Research & Development Engineer, Vascular

Artificial Intelligence (AI)

Community Health

Compensation and Benefits

Corporate Policies

Cross-Functional

FDA (Food and Drug Administration)

GMP (Good Manufacturing Practices)

Healthcare Quality

ISO (International Organization for Standardization)

Industry Standards

Medical Equipment

Mentoring

Metrics

Multitasking

Patient Care

Process Improvement

Product Development

Productivity Management

Project Development

Project/Program Management

Quality Metrics

Regulatory Compliance

Research & Development (R&D)

Team Lead/Manager

Technical Leadership

Time Management

This Senior Clinical Data Scientist partners with cross-functional stakeholders to translate complex clinical and operational problems into analytical strategies, evaluating data risk and delivering insights that inform decision making related to patient safety, study execution, data integrity, and portfolio-level decisions. Capable of acquiring and maintaining Cook Mastery Level of Artificial Intelligence competency, including the ability to assess feasibility and risk of AI use cases, design or coordinate workflow-level AI solutions, guide teams on responsible AI governance, mentor others, and contribute to organizational policies and ethical decision-making.

<h2>Why Join Us</h2>We believe in taking care of our people so they can take care of others. As a global, family-owned company that has been improving patients’ lives since 1963, we’re committed to doing business with integrity and making a positive impact in the communities where we live and work. We’re guided by strong ethical standards and core values, and we believe the best ideas come from creating solutions together. Our company culture values every voice, brings together inclusive teams who collaborate well, and encourages learning and innovation. When you join Cook, you’re not just starting a job, you’re building a career with purpose, in a company that invests in you. What You Can Expect at Cook These are some ways we support our people across Cook:· Meaningful work & strong values: Contribute to improving patient care globally in a company known for high ethical standards and integrity.· Competitive rewards & security: Competitive, performance-related compensation and benefits that support your health and financial wellbeing.· Flexibility & time off: Paid time off, holidays, and hybrid or remote work options for many jobs, where possible.· Growth & development: Learning opportunities, educational assistance, and development programs to help you grow your skills and career.· Wellbeing & community: Health and wellness initiatives, social activities, and community engagement that help you feel connected and supported. Benefits and programs vary by country and job. Our recruiters can provide more information about the specific benefits and programs available in your location.<h2>Overview</h2>The Senior Clinical Data Scientist is an individual contributor responsible for applying advanced analytics, machine learning, AI-driven methodologies, and clinical expertise to generate actionable insights, predictive capabilities, and scalable data solutions. This Senior Clinical Data Scientist partners with cross-functional stakeholders to translate complex clinical and operational problems into analytical strategies, evaluating data risk and delivering insights that inform decision making related to patient safety, study execution, data integrity, and portfolio-level decisions. The role is expected to demonstrate strong aptitude in applied AI, including identifying, designing, and implementing AI-enabled solutions in a responsible, ethical and governed manner.<h2>Responsibilities</h2>Develop and deploy advanced analytical models, including machine learning, predictive modeling, forecasting, and anomaly detection. Apply AI/ML techniques to solve complex business problems and identify patterns, risks, and opportunities within large, multi-source datasets. Design, build, and maintain scalable analytical solutions and reusable data science frameworks. Translate analytical findings into clear, accurate, and actionable insights tailored for technical and non-technical stakeholders. Partner with cross functional teams to ensure insights are actionable and aligned to business priorities. Contribute to the development of KPIs, metrics, and performance measurement frameworks in collaboration with cross-functional stakeholders. Mentor peers and contribute to building data science and AI/ML capabilities across the organization. Apply advanced analytics to patient-level, site-level, and study-level clinical data, processes, and documents to support study design and strategy, execution, oversight, and portfolio insights including potential claims. Integrate and analyze data across clinical systems (e.g., EDC, CTMS, eTMF, safety systems, external data sources) to provide a holistic view of site and study performance and data reliability. Evaluate data quality, data risk, and data completeness in the context of clinical trial conduct, identifying potential impacts to patient safety and endpoint integrity. Ensure analytical approaches align with regulatory authority expectations for electronic records (e.g., data integrity, traceability, reproducibility) and the use of AI in generating outputs. Apply knowledge of Good Clinical Data Management Practices (GCDMP), and regulatory authority expectations to ensure data is not only complete, but credible and fit for decision-making. Support inspection readiness through well-documented processes and auditable analytical outputs. AI & Advanced Analytics ExpectationsDemonstrated experience applying machine learning and AI techniques in production or near-production environments Experience developing predictive models, classification models, or anomaly detection systems Familiarity with model lifecycle management, including validation, monitoring, and performance evaluation Ability to identify and implement AI-driven automation or decision-support solutions Awareness of ethical, regulatory, and governance considerations in AI/ML approaches, development and deployment within clinical research contexts, ensuring alignment with regulatory authority expectations, data privacy requirements, and patient safety considerations. <h2>Qualifications</h2>  Educational Requirements:Bachelor’s degree (Masters or PhD preferred) in Data Science, Biostatistics, Statistics, Computer Science, Biomedical Engineering, or a related quantitative discipline; or equivalent combination of education and experience.Minimum 5–8 years of relevant experience in data science, advanced analytics, or AI/ML.Demonstrated experience working with complex, multi-source datasets in regulated environments.Experience working with patient-level clinical data, clinical operations data, CMS/claims data, or other regulated healthcare datasets strongly preferred.   Technical Skills:Strong proficiency in analytical programming languages and tools (e.g., Python, R, SQL).Experience developing analytical models and data visualization tools (e.g., Power BI).Experience developing and deploying machine learning models.Familiarity with data engineering concepts and working with large datasets. Competencies:Strong problem-solving and analytical thinking skillsAbility to work in ambiguous environments and define analytical approachesStrong communication skills with the ability to translate technical findings into business insightsCollaborative mindset with experience working in cross-functional teamsComfortable working with ambiguous questions and incomplete data while clearly articulating assumptions and limitations.Capable of acquiring and maintaining Cook Mastery Level of Artificial Intelligence competency, including the ability to assess feasibility and risk of AI use cases, design or coordinate workflow-level AI solutions, guide teams on responsible AI governance, mentor others, and contribute to organizational policies and ethical decision-making.Qualified candidates must be legally authorized in the United States. Cook does not intend to provide sponsorship for employment visa status’ for this employment position. Preferred Domain Knowledge:Working knowledge of clinical research systems, and data and documentation management structures (e.g., EDC, CTMS, eTMF, CDISC, CDASH).Understanding of clinical study execution, oversight, and operational workflows within a regulated environment.

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Lead Research & Development Engineer, Vascular Cook Group

Senior Clinical Data Scientist Cook Group

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