The Role
Leads medical device research and development projects, making key design decisions and solving complex engineering challenges. Provides technical leadership and subject matter expertise, collaborates with physicians, product managers, Quality, and Regulatory teams, and develops design history files, processes, procedures, and technical guidance. Supports innovation, intellectual property, project milestones, compliance, and product quality while mentoring colleagues. Requires engineering experience in medical devices or regulated industries and fluency in AI and data concepts.
Summary Generated by Built In
Overview
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.
In this role, they may have the following responsibilities:
- Lead small projects/programs and/or have ownership of portions of medium to large projects/programs while also supporting other project teams, as needed.
- Collaborate across functional department(s), grow and advance their area of technical expertise, and provide guidance and technical leadership within their area.
- Create procedures or white paper guidance for functional groups in focus area(s) of work.
- Continue to perform the functions, duties, and expectations of the Research and Development Engineer 2 at a high level, as applicable.
- Responsibilities for supporting technical leadership may include:
- 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.
- Responsibilities for providing subject matter expertise may include:
- 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.
- Assists 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 with Quality, Regulatory, and company policies and systems.
- May represent Cook in industry standards, working groups and present on Cook’s behalf in industry conferences.
- Act as a mentor to other personnel fostering an environment of collaborative knowledge sharing and continuous learning.
- 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
- 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 tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers.
- Demonstrated fluency in both written and spoken English, and in other local language(s), as applicable.
Skills Required
- Bachelor's degree in Engineering
- At least 5 years of relevant experience; advanced degrees may reduce this requirement by 2–4 years
- Experience in a technical role within the medical device industry, regulated industry, or adjacent field
- Strong analytical and critical-thinking skills
- Strong technical writing skills
- Ability to work cross-functionally to solve complex problems
- Ability to develop new products and processes to achieve functional objectives
- Fluency in artificial intelligence and data concepts, including evaluating AI outputs and mitigating bias or inaccuracies
- Fluency in written and spoken English and applicable local languages
- Project or technical leadership experience
- Knowledge of relevant ISO, EU, and FDA medical device standards and regulations
- Project management methodology and skills
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The Company
What We Do
At Cook, we are building our future on Invention, Connection, People, and Community. As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device. Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
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