Senior Research

Overview Senior 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 Limerick Cook 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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