Lead Research and Development Engineer

Cook Group • Bloomington, IN

2d

About The Position

The Lead Research and Development Engineer is a technical leader and/or growing subject matter expert who applies engineering principles to solve complex technical challenges and ensures products meet clinical needs, safety requirements, and quality standards. The role leads medium to large projects and programs, supports other project teams, collaborates across functions, develops technical expertise, and provides technical leadership across multiple projects. The engineer also works with senior leadership to identify research focus areas and develop best practices.

The position includes leading technical development and key design decisions, conducting retrospective project reviews, implementing strategic goals, and developing subject-matter guidance, procedures, and training. The engineer works with subject-matter experts, physicians, and product managers to develop medical devices, and coordinates project work to meet milestones and business metrics. Responsibilities also include creating and maintaining design history files, improving processes and solutions, contributing intellectual-property and innovation input, and communicating effectively across the global organization. The role may represent Cook in industry standards groups or conferences and mentor other engineers.

Requirements

• Bachelor’s degree in Engineering and 7 years of relevant experience; relevant Master’s or PhD degrees may reduce the experience requirement by 2–4 years.
• Experience in a technical role within the medical device industry, a regulated industry, or an adjacent area.
• Project or technical leadership experience.
• Experience working closely with senior leadership.
• Strong analytical and critical-thinking skills.
• Strong technical writing skills.
• Ability to work with cross-functional teams to solve complex problems.
• Ability to develop and lead elements of new products and processes to achieve functional objectives.
• Knowledge of relevant ISO, EU, and FDA medical-device standards and regulations.
• Strong influencing skills to secure support and buy-in across functions and promote acceptance and understanding of new concepts or approaches.
• Fluency in AI and data concepts, including critically evaluating AI outputs, improving workflows using approved tools, identifying and mitigating bias or inaccuracies, and communicating AI-driven insights clearly and responsibly.
• Fluency in written and spoken English and in other local languages, as applicable.

Nice To Haves

• Experience successfully mentoring, guiding, and training employees within an area of expertise.
• Project management methodology and skills.
• Experience with embolization product and process design for coils and/or other embolic devices.
• Experience obtaining market approval for an embolization product through interactions with regulatory agencies such as the FDA.
• Experience contributing to EU MDR technical documentation and clinical evaluation.
• Experience planning and executing design verification and validation, and process validation (IQ, OQ, PQ).
• Knowledge of FDA guidance for vascular and neurovascular embolization devices.

Responsibilities

• Continue to perform the functions, duties, and expectations of a Senior Research and Development Engineer at a high level, as applicable.
• Lead technical development of medium to large projects and programs, including key design decisions that ensure selected designs meet customer needs.
• Conduct retrospective project reviews to identify lessons learned and implement strategic goals within the area of expertise.
• Work with senior leadership to identify focus areas for projects across functional departments.
• 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, as applicable.
• Lead project activities and drive tasks to meet milestones and business metrics in collaboration with project managers when assigned.
• Interpret data and organize, execute, and coordinate activities within portions of projects or programs, as needed.
• Lead development and execution of activities and documentation to create and maintain design history files.
• Develop and implement processes and solutions that affect department business metrics.
• Advance subject-matter specialization across the department and apply current industry practices to improve technology, processes, and practices.
• Provide technical and strategic input on company intellectual property relevant to projects, programs, or the area of expertise.
• Lead creative problem-solving to develop and implement medical devices and technologies and address complex engineering challenges.
• Build, communicate, and manage relationships with cross-functional groups throughout the global organization to achieve business metrics and project milestones.
• Apply organizational business processes and systems relevant to the role and ensure compliance with Quality, Regulatory, and company policies and systems.
• Represent Cook in industry standards working groups and present on Cook’s behalf at industry conferences, as applicable.
• Mentor and support engineers, fostering collaborative knowledge sharing and continuous learning.

Benefits

• Competitive, performance-related compensation and benefits supporting health and financial wellbeing.
• Paid time off and holidays.
• Hybrid or remote work options for many jobs, where possible.
• Learning opportunities, educational assistance, and development programs.
• Health and wellness initiatives.
• Social activities and community engagement.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior