Research and Development Engineer 2

• 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.

• 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

Cook Medical