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

OTHER

FEED

Overview: Cook Advanced Technologies (Cook AT) offers an exciting start-up atmosphere with the security of a large company and is passionate about making a difference in improving the health and well-being of patients worldwide. Qualifications: Education & Experience: Bachelor’s or Masters degree in Electrical or Computer Engineering or related field, or 5 years equivalent experience in medical device industry.

Overview:
Cook Advanced Technologies (Cook AT) offers an exciting start-up atmosphere with the security of a large company and is passionate about making a difference in improving the health and well-being of patients worldwide.  Cook AT is currently accepting applications for a Research Engineer with an electrical design background.  The person in this position is responsible for executing project deliverables that support the development and evaluation of innovative design concepts for medical products and therapies. This role primarily focuses on electrical, electronic, and electromechanical design within Cook Advanced Technologies, and may also support other Cook companies as needed. 

Responsibilities:
<ul><li style="margin-left:0.25in">Work collaboratively with key stakeholders to define functional, usability, manufacturability, and safety requirements for concept solutions.</li><li style="margin-left:0.25in">Brainstorm design solutions for addressing defined requirements</li><li style="margin-left:0.25in">Design and prototype medical device concepts, including:         - Embedded control systems (ARM, Atmel, PIC, FPGA)  - Software and firmware development   - Analog and digital sensor integration   - Circuit layout and fabrication   - Data acquisition and signal processing systems  - Mechanical packaging</li></ul><ul><li style="margin-left:0.25in">Perform testing, troubleshooting, and validation of prototypes.</li><li style="margin-left:0.25in">Ensure compliance with relevant safety standards, particularly IEC 60601.</li><li style="margin-left:0.25in">Maintain thorough documentation of project work, including reports, lab notebooks, invention disclosures, and meeting notes.</li><li style="margin-left:0.25in">Support intellectual property development by identifying, characterizing, and protecting novel ideas.</li><li style="margin-left:0.25in">Complete training on applicable Quality System procedures and understand the importance of engineering work in achieving quality objectives and ensuring safe, effective medical devices.</li><li style="margin-left:0.25in">Demonstrate initiative and self-direction in all aspects of work.</li></ul>

Qualifications:
Education & Experience:<ul><li style="margin-left:0.25in">Bachelor’s or Masters degree in Electrical or Computer Engineering or related field, or 5 years equivalent experience in medical device industry. </li></ul>Technical Skills:<ul><li style="margin-left:0.25in">Proficient in at least two of the following programming languages: Python, C, C++, R, and MATLAB</li><li style="margin-left:0.25in">Proficient with hardware/software integration</li><li style="margin-left:0.25in">Proficient with programming for data acquisition, signal processing, sensor integration, and control instrumentation</li><li style="margin-left:0.25in">Proficient at instrumentation design, including schematic design, component specification, PCB layout, mechanical packaging, assembly and troubleshooting</li><li style="margin-left:0.25in">Knowledge of RF design techniques</li><li style="margin-left:0.25in">Knowledge of common AI/ML models</li><li style="margin-left:0.25in">Knowledge of mechanical model creation with computer aided design software (SolidWorks preferred)</li></ul>Professional Attributes:<ul><li style="margin-left:0.25in">Strong planning and organizational skills with the ability to prioritize tasks and meet deadlines</li><li style="margin-left:0.25in">Effective communication and collaboration skills across cross-functional teams</li><li style="margin-left:0.25in">Ability to work in a regulated environment</li><li style="margin-left:0.25in">Professional demeanor, positive attitude, and strong work ethic</li></ul>Qualified candidates must be legally authorized to be employed in the United States. Cook Advanced Technologies does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN) for this employment position.

Research Engineer, Electrical Design

ARM (Advanced RISC Machine)

C Programming Language

C++ Programming Language

CAD (Computer-Aided Design) Software

Communication Skills

Computer Engineering

Computer Firmware

Control Systems

Design Evaluation

Documentation

Electrical Design

Electrical Engineering

Electricity

Electromechanical Design

Electronic Design

Embedded Systems

Establish Priorities

FPGA

Hardware-Software Integration

Identify Issues

Instrumentation

Intellectual Property Development

International Electro-Technical Commission (IEC)

Invention Disclosures

Laboratory Notebook

MATLAB

Maintain Compliance

Mechanical Assembly

Medical Products

Medical Treatment

Meeting Minutes

Organizational Skills

Printed Circuit Board (PCB) Layout

Programming Languages

Prototyping

Python Programming/Scripting Language

R Programming Language

Radio Frequency

Requirements Management

Safety Compliance

Safety Standards

Safety Training

Schematics

Signal Processing

Software Development

SolidWorks

Startup

Team Player

Testing

Usability Engineering

[AW]-iCims

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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Research Jobs in Bedford Heights, IN

Lead Research & Development Engineer, Vascular Cook Group

Research Engineer, Electrical Design Cook Group

Senior Clinical Data Scientist Cook Group

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