Overview:
Lead Research & Development team in the design, development and taking to market of medical devices for the Cook Vascular division
Reporting to: Research & Development Manager or Senior 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 or Senior 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 orr the Senior Test Engineer 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.
• 5+ 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.

• 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 or Senior 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 orr the Senior Test Engineer if required.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf