Lead Research and Development Engineer

Cook Group

. Serve as a technical leader and/or growing subject matter expert applying engineering principles to solve complex technical challenges .

Posted 11/4/2026full-timeBloomington • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in engineering principles and project leadership within the medical device industry, ensuring compliance with regulatory standards while driving innovation and collaboration across functional teams.

Highest-signal resume keywords

Project ManagementTechnical LeadershipMedical Device StandardsAnalytical SkillsTechnical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Engineering PrinciplesProject LeadershipDesign VerificationProcess ValidationISO StandardsFDA RegulationsAI ConceptsData AnalysisEmbolization Product DesignClinical Evaluation

Soft Skills

CollaborationInfluencing SkillsProblem-SolvingMentoringCritical Thinking

Industry Keywords

Medical DeviceRegulated IndustryQuality ComplianceRegulatory AgenciesMarket ApprovalDesign History FilesCross-Functional TeamsInnovationBest PracticesStrategic Goals

About the role

Key responsibilities & impact

Serve as a technical leader and/or growing subject matter expert applying engineering principles to solve complex technical challenges
Ensure products meet clinical needs, safety requirements, and quality standards
Lead medium to large projects/programs while supporting other project teams as needed
Collaborate across functional departments and provide technical leadership across multiple projects
Work with senior leadership to identify focus areas for research and best practices
Lead technical development and key design decisions for medium to large projects/programs
Conduct retrospective project reviews and implement strategic goals within the area of expertise
Conduct research and contribute to best practices
Create procedures or white paper guidance for functional groups
Deploy knowledge and training and ensure correct implementation of new concepts and approaches
Work with subject matter experts, physicians, and product managers to develop innovative medical devices
Drive project tasks, milestones, and business metrics in collaboration with project managers
Interpret data and organize, execute, and coordinate project activities
Lead development and execution of activities and documentation for design history files
Develop and implement new processes and solutions affecting department business metrics
Drive subject matter specialization and improve existing technology, processes, and practices
Provide technical and strategic input on intellectual property and drive innovation and IP generation
Lead creative problem-solving to develop and implement medical devices and technologies
Build and manage relationships with cross-functional groups throughout the global organization
Apply organizational business processes and systems
Ensure compliance with Quality, Regulatory, and company policies and systems
Represent Cook in industry standards working groups and conferences
Mentor and support engineers, fostering collaborative knowledge sharing and continuous learning

Requirements

What you’ll need

Bachelor’s degree in Engineering and 7 years’ relevant experience
Relevant advanced degrees (Master’s or PhD) may reduce the experience requirement by 2–4 years
Experience in a technical role within Medical Device or regulated industry/adjacent experience
Project/technical leadership experience
Experience working closely with senior leadership
Strong analytical and critical thinking skills
Strong technical writing
Proven ability to work with cross functional teams to solve complex problems
Proven ability to develop and lead elements of new products and processes in achieving functional objectives
Knowledge of relevant ISO, EU, FDA medical devices standards regulations
Strong influencing skills required to secure support/buy-in across the function
Project management methodology and skills is preferred
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
Demonstrated fluency in both written and spoken English, and in other local language(s), as applicable
Experience with embolization product(s) and process design for coils and/or other embolic devices is preferred
Successful market approval for embolization product through interactions with relevant regulatory agencies (e.g. FDA) is preferred
Input to EU MDR technical documentation and clinical evaluation is preferred
Planning and execution of design verification and validation, and process validation (IQ, OQ, PQ) is preferred
FDA guidance for vascular and neurovascular embolization devices is preferred
Ability to work under general office environmental conditions
Ability to sit for extended periods and utilize close visual acuity for working with computers
May require occasional travel

Benefits

Comp & perks

Competitive, performance-related compensation and benefits
Paid time off
Holidays
Hybrid or remote work options for many jobs, where possible
Learning opportunities
Educational assistance
Development programs
Health and wellness initiatives
Social activities
Community engagement