Senior Research

Overview

The purpose of this role is to work as part of the Research and Development team in the design, development and taking to market of medical devices for Cook Medical.

Reporting to: Team Lead, Research and Development / Manager, Research and Development

Responsibilities

- Perform Duties of Senior Research and Development Engineer:

- Design development

- Prototyping and test method design.

- Design and/or 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 and Development team/s including technical and project management leadership responsibility:

- 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 team members if required:

- Foster innovation and creativity within team and perform disclosure reviews.

- Ensure 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.

- 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 for the Manager, Research and Development or Team Lead, Research and Development.
- Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.

Qualifications

- Bachelor's degree required, preferably in engineering or a related field.
- Minimum of 5 years' relevant experience is required.
- Experience in Product Development projects within Medical Device or regulated industry/adjacent experience.
- Proven project/technical experience.
- Project management methodology and skills.
- Proven experience working closely with project managers.
- Knowledge of medical device quality standards ISO13485/FDA practices, EUMDR, GMP and similar regulated industry standards.
- Strong statistical understanding and experience e.g. DOE and/or Gage R&R.
- Strong technical writer.
- Good working knowledge of Solidworks and/or Pro Engineer CAD.
- Experience of medical device development from concept through to commercialisation.
- Ability to effectively translate needs of clinicians and Strategic Business Unit into project inputs.
- Willingness and availability to travel on company business.

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