Senior Research & Development Engineer

Senior Research & Development Engineer

Cook Medical

Limerick, Ireland

Overview

Work as part of a Research & Development team in the design and process development of medical devices to take to market for the MedSurg Division.

Reporting to: Research & Development Manager or Research & Development Team Leader.

Responsibilities

Perform Duties of Senior Research & Development Engineer:

  • Design and process development:
    • Prototyping and test method design.
    • Design and 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 (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, if required.
    • Lead technical development of projects.
    • Lead 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.
  • 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 or R&D Team leader.
  • 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 or Research & Development Team leader, if required.
  • 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, Science, Design or similar discipline, Masters or Ph.D. level preferred but not essential.
  • 7+ years’ experience.
  • Proven Project Leadership abilities.
  • Experience in DOE and/or Gage R&R is preferred.
  • Strong statistical understanding and experience, including good working knowledge of Excel and/or Minitab.
  • 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, EU Medical Device Regulation 2017/745, (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 business division into project inputs.
  • Willingness and availability to travel on company business.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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