Lead Research and Development Engineer

Cook Group • Bloomington, IN

4d

About The Position

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

The role leads technical development and key design decisions, conducts retrospective project reviews, and implements strategic goals within areas of expertise. It develops procedures and guidance, trains teams on new concepts, and may work with subject matter experts, physicians, and product managers to develop medical devices. The position drives project milestones and business metrics, develops and maintains design history files, and advances processes, technologies, and practices. It also contributes technical and strategic input on intellectual property, represents Cook in industry groups or conferences when applicable, and mentors engineers across the organization.

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 or regulated industry, or adjacent experience.
• 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 the function and drive 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 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 products and process design for coils or other embolic devices.
• Successful market approval for an embolization product through interactions with relevant 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.
• Lead key design decisions to ensure design selections meet customer needs and quality expectations.
• Conduct retrospective project reviews and identify lessons learned.
• Implement strategic goals within the area of expertise.
• Work with senior leadership to identify focus areas across functional departments and contribute to research and best practices.
• Create procedures or white-paper guidance for functional groups, and deploy knowledge and training to 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 tasks to achieve 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 applicable.
• Lead development 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 stay current with industry practices, technologies, processes, and methods.
• Provide technical and strategic input on company intellectual property related to projects or areas of expertise to drive innovation and IP generation.
• Lead creative problem-solving to develop and implement medical devices and technologies, address complex engineering challenges, and improve product and process excellence.
• Build and manage effective relationships with cross-functional groups throughout the global organization to achieve business metrics and project milestones.
• Apply organizational business processes and systems relevant to assigned duties and responsibilities.
• Ensure work complies 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