Research and Development Engineer 2

The primary responsibility of this position is to lead the Design History File (DHF) and Design Control activities relating to the design, development and taking to market of medical devices for the Cook Vascular Division.

Reporting to: Team Lead, Research and Development / Manager Research and Development

Find out more about Cook Medical here

• Develop and maintain an understanding of Cook Medical Design Controls, Process Development and Risk Management policies, procedures and systems.
• Collaborate cross functionally during the New Process Development  (NPD) process to create/update the DHF docements including preliminary hazard analysis, design inputs requirements, FMEA's, design standards and desighn verification and validation protocols and reports.
• Use web-based product development and compliance software (i.e. Cognition Cockpit) throughout DHR creation process.
• Ensure traceability throughout the DHF to demonstrate that design outputs meet design inputs and that all requirements are tested appropriately.
• Collaborate with cross functional teams such as Design Assurance, Product Management, Quality Assurance, Regulatory Affairs and Clinical Affairs to gather necessary documentation and information specific to DHF creation process, ensuring alignment with regulatory standards and best practices.
• Other responsibilities may include:
  • Design development, prototyping, test method design, design evaluation , design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner.
  • Product testing and evaluation, completion of test reports to support design selection.
  • Preparation and presentation of design reviews.
  • Product and project risk analysis and risk management.
  • Work with Process Development Engineering to introduce/develop new equipment and production processes as required for any new manufacturing techniques.
  • Source new materials components and equipment.
  • Development of component specifications, inspection methods, bills of materials and manufacturing processes.
  • Introduction of new equipment, materials and technologies.
• Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.
• Project lead for assigned research & development projects including technical and project management responsibly.
  • Manage and drive project tasks to ensure timely completion of project milestones.
  • Work closely with cross functional groups to achieve project and company goals.
  • Product performance evaluations.
  • Contribute to innovation and creativity within team through filing of disclosures and patents.
  • Hold regular project meetings and document minutes and actions.
  • Ensure project milestones are achieved to meet business metrics.
• Compliance with Quality, Regulatory and company policies and systems.
• Communications:
  • Regular communication to cross-functional teams, senior management and business unit leaders.
  • Project status communications and reporting.
• Remain on the forefront of emerging industry practices.
• Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products.
• Support other cross functional groups to deliver company goals.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

• Bachelor's degree is required, preferably in engineering or a related field. 
• Minimum of 3 years' relevant experience is required. 
• Experience across a broad range of Design Controls, Process Development and Risk Management procedures and systems
• Experience working with DHF documentation such as preliminary hazard analysis, design inputs requirements, FMEA's, design standards and desighn verification and validation protocols and reports.
• Experience with web-based product development and compliance software for medical devices such as Cognition Cockpit.
• Project planning skills.
• Execution of project in a timely effective manner.
• Knowledge of anatomy and physiology.
• Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
• Manufacturing design and process understanding.
• Good working knowledge of Solidworks and/or Pro Engineer CAD.
• Strong technical writer.
• Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820), EU Medical Device Regulation 2017/745.
• Team Player with ability to develop strong working relationships.
• Strong communication and inter-personal skills.
• Good problem solving skills.
• Highly motivated individual, self-starter with a passion for excellence.
• Must be able to work in a fast paced environment.
• Willingness and availability to travel on company business.

About Cook Limerick  

Cook Medical has been in Limerick since 1996, starting out with labeling and 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 Cook’s 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 and Medsurg. The R&D engineering teams are responsible for bringing 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 engineers have the opportunity to create novel ideas within feasibility, learn and 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 pension scheme   
• 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, nutrition talks   
• Fully equipped gym on site   
• 39-hour week with flexible start & finish times    
• Paid time off to participate in volunteer activities   
• Free parking   
• Subsidised restaurant   
• Sports & Social club 

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