Senior Research & Development Engineer

Requisition ID
2021-9588
Job Location(s)
Limerick Ireland
Languages Required
English
Company
Cook Ireland
Position Type
Full Time
Category
Engineering
Education
Bachelor's Degree, Master's Degree

Overview

Lead Research & Development team in the design, development and taking to market of medical devices for the Vasular division.

 

In addition to the responsibilities below, this role will focus on the development of the drug containing part of our Vascular Drug-Device Combination Products.  Candidates will need to have prior experience in the creation of final specifications for drug coated devices and the execution of design verification of the Drug Containing Part.  Additionally, candidates will be required to have a good working knowledge of ICH regulations, applicable USP chapters and relevant FDA guidelines for Drug-Device Combination Products.

 

Reporting to: Research & Development Manager  

 

 

Find out more about Cook Medical here

Responsibilities

  • Perform Duties of Senior Research & Development Engineer:
    • 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 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.
  • 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 team/s including technical and project management leadership responsibly.
    • Lead technical development of projects.
    •  Lead all key design decisions to ensure quality design selection.
    • Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved.
    • Work closely to 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 direct reports if required.
    • Foster innovation and creativity within team and perform disclosure reviews.
    • 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.
    • Ensure effective reporting to the R&D Manager
  • Remain on the forefront of emerging industry practices.
  • Instrumental in driving and implementing change to improve departmental and company performance.
  • 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.
  • Act as a designee of the Research & Development Manager and the Senior Test Engineer.
  • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

  • Third level degree in Mechanical, Biomedical or similar discipline, Masters or Ph.D. level preferred but not essential.
  • 7+ years’ experience is ideal.
  • Proven Project Leadership abilities.
  • Good Project Management methodology and skills.
  • Proven track record in delivering quality results in a timely effective manner.
  • Knowledge of anatomy and physiology.
  • Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
  • Innovative/Creative Engineer.
  • Good manufacturing design and process understanding.
  • Good working knowledge of Solidworks and/or Pro Engineer CAD.
  • Good presentation skills (working knowledge of MS PowerPoint).
  • Strong technical writer.
  • Attention to detail and Quality focus.
  • Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820).
  • 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.
  • Ability to foster relationships with key stakeholders required to ensure on time project delivery.
  • Experience of medical device development from concept through to commercialisation.
  • Ability to effectively translate needs of clinicians and SBU into project inputs.
  • Willingness and availability to travel on company business.

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