Research and Development Engineer 2

About Cook Limerick

Cook Medical has been in Limerick since 1996 starting out withlabelingand distribution and steadily growing and evolving to include manufacturing centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cooks products for global markets.

Research and Development in Limerick

Our mission with R&D is to invent manufacture and deliver a unique portfolio of medical devices to the healthcare systems of the world.

Our R&D team in Limerick is split into two divisions Vascular andMedsurg. The R&D engineering teamsare responsible forbringing a product from idea or concept all the way to market launch.

The R&D Vascular division in Limerick has two programs peripheral arterial disease (PAD)and venous therapies.The R&D engineershave the opportunity tocreate novel ideas within feasibilitylearnand meet the requirements to bring a medical device through verification and validation generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies.

Our employee benefits include:

• Hybrid Work Model

• Company sponsored Defined Contribution pensionscheme

• Medical Health Insurance cover for you and your immediate family

• Life Assurance and Income Protection cover

• Educational Assistance

• Performance related Bonus

• Extensive health & wellness program including Indian head massages healthy lifestyle seminars mindfulness courses physio sessions flu vaccinations nutritiontalks

• Fully equipped gym on site

• 39-hour week with flexible start & finish times

• Paid time off toparticipatein volunteeractivities

• Free parking

• Subsidised restaurant

• Sports & Social club

The Researchand Development Engineer 2 will be a technical leader and/or growing subject matter expert applying engineering principles to solve technical challenges and ensuring products meet clinical needs safety requirements and quality standards.

In this role they may have the following responsibilities:

• Lead portions of 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.

• Contribute to the development of best practices in focusarea(s)of work.

• Continue to perform the functions duties and expectations of the Research and Development Engineer 1 at a high level as applicable.

• Responsibilities for supporting technical leadership may include:

• Leading technical development for portions of projects/programs.

• Support key design decisions to ensure quality of design selection to meet customer needs.

• Attainment of goals within area of expertise.

• Responsibilities for providing subject matter expertise may include:

• Work within project/program team(s) 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).

• Support and contribute to the creation of procedures or white paper guidance for functional groups.

• Deploy knowledge and support the correct implementation of new concepts and/or approaches.

• Interact with SMEs physicians and product managers to develop innovative medical devices to improve patient care as applicable.

• Assumesresponsibilityin interpreting data organizing executing and coordinating project activities within portions of projects/programs.

• Develop 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.

• Utilize and implement engineering knowledge and technical expertise to support the department.

• Provide technical input on company intellectual property relevant to area of work to drive innovation and IP generation.

• Assist with 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 within the department.

• Collaborate communicate and manage effective relationships with cross functional groups to support the achievement of project milestones.

• Learn the organizations business processes and systems as applicable to your duties and responsibilities.

• Comply with Quality Regulatory and company policies and systems.

• Bachelors degree in Engineering and 3 years relevant experiencerequired. Relevant advanced degrees (Mastersor PhD) may reduce the experience requirement by 2-4 years.

• Experience in a technical role within Medical Device or regulated industry/adjacent experience. Vascular delivery systems stents or stent grafts would be an advantage.
• Min 2-3 years solid experience generating DHF documentation (risk management design inputs design standards test protocols & reports) for Class III medical devices.
• Experience in sterilisation animal studies microbiology and biocompatibility would be an advantage.
• Strong analytical and critical thinking skills.
• Strong technical writing.
• Ability to work with cross functional teams to solve complex problems.
• Knowledge of relevant ISO EU FDA medical devices standards regulations is preferred.
• This role requires fluency in Artificial Intelligence (AI) and data concepts including the ability to critically evaluate AIoutputs improve workflows using approved tools identify and mitigate bias or inaccuracies and communicate AI-driven insights clearly and responsibly to peers and managers.
• Must be able to perform the essential functions of the job subject to reasonable accommodation requirements as applicable by local regional or national law or regulation.
• Work under general office environmental conditions
• Sitting for extendedperiodsutilizes close visual acuity for working with computers etc.
• In line with local health and safety requirements personal protective equipment may be required in areas associated with this position.
• May require occasional travel.
• Each employee must acknowledge and agree to comply with all written company policies procedures and standards including without limitation the Employee Manual/Handbook (local regional and if applicable company-specific) Code of Conduct (Cook Medical and Cook Group) Electronic Information Policy HIPAA regulations and any Non-Competition and Confidentiality Agreement.

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