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.
Position: Research & Development Engineer 2
Reporting to: Team Lead, Research and Development / Manager, Research and Development

Responsibilities:

• Perform Duties of Research & Development Engineer 2:
• 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.
• Product testing and evaluation, completion of test reports to support design selection.
• Preparation and presentation of design reviews.
• Product risk analysis and risk management.
• Contribute towards process development during introduction /development of new equipment and production processes as required for any new manufacturing techniques.
• Source new materials components and equipment.
• Development of component specifications, inspection methods, bills of materials and manufacturing processes.
• 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:
• Manage and drive assigned project tasks to ensure timely completion of project milestones.
• Work closely with cross functional groups to achieve project and company goals.
• Product performance evaluations.
• Contribute to innovation and creativity within team through filing of disclosures and patents.
• Hold regular project meetings and document minutes and actions.
• Ensure project milestones are achieved to meet business metrics.
• Communications:
• Regular communication to cross-functional teams and senior management.
• 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.

• Perform Duties of Research & Development Engineer 2:
• 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.
• Product testing and evaluation, completion of test reports to support design selection.
• Preparation and presentation of design reviews.
• Product risk analysis and risk management.
• Contribute towards process development during introduction /development of new equipment and production processes as required for any new manufacturing techniques.
• Source new materials components and equipment.
• Development of component specifications, inspection methods, bills of materials and manufacturing processes.
• 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:
• Manage and drive assigned project tasks to ensure timely completion of project milestones.
• Work closely with cross functional groups to achieve project and company goals.
• Product performance evaluations.
• Contribute to innovation and creativity within team through filing of disclosures and patents.
• Hold regular project meetings and document minutes and actions.
• Ensure project milestones are achieved to meet business metrics.
• Communications:
• Regular communication to cross-functional teams and senior management.
• 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