OverviewSenior Research & Development Engineer (MedSurg) at Cook Medical. The purpose of this role is to work as part of the Research and Development team in the design, development and taking to market of medical devices for Cook Medical.Reporting to: Team Lead, Research and Development / Manager, Research and Development.Find out more about Cook Medical here.Responsibilities
Perform Duties of Senior Research and Development Engineer
Design development
Prototyping and test method design
Design and/or process evaluation, reviews, specifications, verification and validation, protocols and reports and transfer to production activities in a timely and effective manner
Product and project risk analysis and risk management
Develop prototypes which are consistent with the clinical and design requirements of the project
Research new therapies and design solutions to develop and complement the existing product portfolio
Introduce new equipment, materials and technologies
Generation of Design History File documentation
Support of regulatory submissions
Work closely with Key Opinion Leaders (KOLs), physicians and product managers to develop innovative medical devices to improve patient care
Project lead for assigned R&D teams including technical and project management leadership
Lead technical development of projects
Lead all key design decisions to ensure quality design selection
Manage the activities of the project team and drive tasks to ensure timely completion of milestones
Build effective relationships with cross-functional groups to achieve project and company goals
Retrospective project reviews to understand lessons learned
Manage device evaluations
Compliance with Quality, Regulatory and company policies and systems
Mentoring, coaching and development of team members
Foster innovation and creativity within team and perform disclosure reviews
Ensure 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
Drive change to improve departmental and company performance
Educate oneself in the medical area for which the new devices are being developed
Support other cross-functional groups to deliver company goals
Act as a designee for the Manager, Research and Development or Team Lead, Research and Development
Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf
Qualifications
Bachelor’s degree required, preferably in engineering or a related field
Minimum of 5 years’ relevant experience
Experience in Product Development projects within Medical Device or regulated industry/adjacent experience
Proven project/technical experience
Project management methodology and skills
Proven experience working closely with project managers
Knowledge of medical device quality standards ISO13485/FDA practices, EUMDR, GMP and similar regulated industry standards
Strong statistical understanding and experience (e.g., DOE and/or Gage R&R)
Strong technical writing skills
Working knowledge of SolidWorks and/or Pro/Engineer CAD
Experience of medical device development from concept through to commercialisation
Ability to translate needs of clinicians and Strategic Business Unit into project inputs
Willingness and availability to travel on company business
About Cook LimerickCook Medical has been in Limerick since 1996, with manufacturing, centralised customer support and collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location employs more than 1,000 people and manufactures 10% of Cook’s products for global markets.
Research and Development in Limerick Our mission is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. The R&D team in Limerick is split into Vascular and MedSurg, responsible for taking a product from idea to market launch. The MedSurg R&D team manages Endoscopy/EndoSurgery and OHNS programs and collaborates with Cook’s sister site in Winston Salem, NC.
Employee Benefits
Hybrid Work Model
Company sponsored Defined Contribution pension
Medical Health Insurance for you and your immediate family
Life Assurance and Income Protection
Educational Assistance
Performance related Bonus
Health & wellness program including various well-being activities
Fully equipped on-site gym
39-hour week with flexible start & finish times
Paid time off for volunteer activities
Free parking
Subsidised restaurant
Sports & Social club
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