Research & Development Engineer Medsurg - Cook Group

Overview

Work as part of a Research & Development team to create new medical solutions for the MedSurg Division that advance patient outcomes by using an in-depth understanding of the current and future state of relevant clinical, market and technological areas.

Reporting to: Program Manager Global Endoscopy, or Global Research & Development Manager  

Find out more about Cook Medical here

Responsibilities

• Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.
• Perform Duties of a Research & Development Engineer:
• o Develop prototypes which are consistent with the clinical and design requirements of the project.
• o Research new therapies and design solutions to develop and complement the existing product portfolio.
• o Introduce new materials, technologies, and equipment.
• o 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.
• o Product and project risk analysis and risk management.
• o Generation of Design History File documentation.
• o Support of regulatory submissions.
• Project lead for assigned Research & Development team/s including technical and project management leadership responsibly, if required.
• o Lead technical development of projects.
• o Lead key design decisions to ensure quality design selection.
• o Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved.
• o Work closely to build effective relationships with cross functional groups to achieve project and company goals.
• o Retrospective project reviews to understand lessons learned.
• o Manage device evaluations.
• o Compliance with Quality, Regulatory and company policies and systems.
• Communications:
• o Regular communication to cross-functional teams, senior management and business unit leaders.
• o Project status communications and reporting.
• o 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.
• 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.
• 3+ years’ experience.
• Innovative/Creative Engineer.
• Entrepreneurial mindset with track record of identifying market opportunities and customer needs.
• Ability to effectively translate needs of clinicians and business division into project inputs.
• Ability to rapidly generate prototype devices.
• Good Project Management methodology and skills.
• Team Player with ability to develop strong working relationships.
• Strong communication and inter-personal skills.
• Good problem solving skills.
• Proven track record in delivering quality results in a timely effective manner.
• Knowledge of anatomy and physiology.
• 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.
• Proven Project Leadership abilities.
• Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
• 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).
• Experience of medical device development from concept through to commercialisation.
• Experience in DOE and/or Gage R&R is preferred.
• Statistical understanding and experience, including good working knowledge of Excel and/or Minitab is preferred.
• Willingness and availability to travel on company business.
•