Headcount Solutions are seeking to recruit a
Senior Research & Development Engineer for one of our multinational clients in Limerick.
Senior Research & Development Engineer
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
Contract
/
Permanent
Responsibilities:
* 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 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 team members if required.
* Foster innovation and creativity within team and perform disclosure reviews.
Ensure compliance with Quality, Regulatory and company policies and systems.
* 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.
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 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.
* 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.