Overview
The primary responsibility of this position is to support / lead on 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 Research & Development Engineer 2:
o 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 effective manner.
o Product testing and evaluation, completion of test reports to support design selection.
o Preparation and presentation of design reviews.
o Product risk analysis and risk management.
o Contribute towards process development during introduction /development of new equipment and production processes as required for any new manufacturing techniques.
o Source new materials components and equipment.
o Development of component specifications, inspection methods, bills of materials and manufacturing processes.
o Introduction of new equipment, materials and technologies.
* As required work closely with Key Opinion Leaders, physicians, product managers and team to develop innovative medical devices to improve patient care.
* Work closely with Project Lead and take responsibility for assigned research and development project tasks:
o Manage and drive assigned project tasks to ensure timely completion of project milestones.
o Work closely with cross functional groups to achieve project and company goals.
o Product performance evaluations.
o Contribute to innovation and creativity within team through filing of disclosures and patents.
o Hold regular project meetings and document minutes and actions.
o Ensure project milestones are achieved to meet business metrics.
* Communications:
o Regular communication to cross-functional teams and senior management.
o Project status communications and reporting.
* Remain on the forefront of emerging industry practices.
* 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
* Bachelor's degree is required, preferably in engineering or a related field.
* Minimum of 3 years' relevant experience is desired.
* Project planning/execution skills.
* Execution of project in a timely effective manner.
* Knowledge of anatomy and physiology.
* Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge.
* Statistical understanding and experience.
* Manufacturing design and process understanding.
* Good working knowledge of Solidworks and/or Pro Engineer CAD.
* Strong technical writer.
* Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
* Willingness and availability to travel on company business.