Senior Research and Development Engineer

Senior Research and Development Engineer

Company:
Cook Inc – Bloomington, Indiana, United States

Location:

Bloomington, IN

The Senior Research and Development Engineer will be a technical leader and/or growing subject matter expert, applying engineering principles to solve complex technical challenges and ensuring products meet clinical needs, safety requirements, and quality standards.

• Continue to perform the functions, duties, and expectations of the Research and Development Engineer 2 at a high level, as applicable.
• Supporting technical leadership:
  • Leading technical development of small projects/programs and/or ownership of portions of medium to large projects/programs.
  • Leading all key design decisions to ensure quality of design selection to meet customer needs.
  • Retrospective project reviews to understand lessons learned.
  • Implementation of strategic goals within area of expertise.
• Providing subject matter expertise:
  • Work with senior leadership to identify and agree on focus area(s) for their projects across the functional department(s).
  • Conduct research and contribute to the development of best practices in focus area(s).
  • Create procedures or white paper guidance for functional groups.
  • Deploy knowledge, training, and ensure correct implementation of new concepts and/or approaches.
• Work closely with SME's, physicians, and product managers to develop innovative medical devices to improve patient care, as applicable.
• Lead the activities of small projects/programs and drive project tasks to ensure timely completion of project milestones, and that business metrics are achieved in collaboration with project manager(s) (when one is assigned).
• May also assume responsibility in interpreting data, organizing, executing, and coordinating project activities within portions of projects/programs.
• Lead the development and execute activities and documentation to create and maintain design history files.
• Assist with the development and implementation of new processes and solutions that will impact the achievement of the department business metrics.
• Implement subject matter area specialization to support the department.
• Provide technical input on company intellectual property relevant to area of work to drive innovation and IP generation.
• Utilize innovative and creative problem-solving techniques to develop and implement cutting edge medical devices and technologies, overcoming complex engineering challenges and driving product/process excellence to support projects/programs across functional groups.
• Build, communicate, and manage effective relationships with cross functional groups to achieve business metrics and project milestones.
• Apply the organization's business processes and systems, as applicable to your duties and responsibilities.
• Ensure compliance with Quality, Regulatory, and company policies and systems.
• May represent Cook in industry standards working groups and present on Cook's behalf at industry conferences.
• Act as a mentor to other personnel fostering an environment of collaborative knowledge sharing and continuous learning.

Essential Regional or Country Requirements Education and/or Work Experience

• Bachelor's degree in Engineering and 5 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 preferred.

Preferred Experience

• Has led 3+ products through regulatory submission.
• Experience supporting Vascular products.

Knowledge and Skills and/or Abilities

• Strong analytical and critical thinking skills.
• Strong technical writing.
• Proven ability to work with cross functional teams to solve complex problems.
• Ability to develop new products and processes in achieving functional objectives.
• Knowledge of relevant ISO, EU, FDA medical devices standards regulations is preferred.
• Project management methodology and skills is preferred.
• This role requires fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved…