Senior Research & Development Engineer

CPL

Limerick

Senior Research & Development Engineer - Med Surg. The primary purpose of this position is to work as part of a Research & Development team in the design and process development of medical devices to take to market for the MedSurg Division. Responsibilities: • Perform Duties of Senior Research & Development Engineer: Design and process development: Prototyping and test method design.  • Design and 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. • 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 & Development team/s including technical and project management leadership responsibly, if required. • Lead technical development of projects. Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved. Manage device evaluations. • Mentoring, coaching and development of direct reports, if required. Foster innovation and creativity within team and perform disclosure reviews. • 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 or Research & Development Team leader, if required.  Qualifications / Requirements: • Third level degree in Mechanical, Biomedical, Science, Design or similar discipline, Masters or Ph.D. level preferred but not essential. • Minimum 5+ years’ experience. • Proven Project Leadership abilities. • Experience in DOE and/or Gage R&R is preferred. • Strong statistical understanding and experience, including good working knowledge of Excel and/or Minitab.  • 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 working knowledge of Solidworks and/or Pro Engineer CAD. Good presentation skills (working knowledge of MS PowerPoint. • Good working knowledge of medical device quality & regulatory systems and medical device directives, EU Medical Device Regulation 2017/745, (ISO13485 and FDA CFR 820. • 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 business division into project inputs. • Willingness and availability to travel on company business.  The Offer: This is a full time/permanent position with an extremely competitive salary with benefits include: • Company sponsored Defined Contribution pension scheme. • Medical Health Insurance cover for you and your immediate family. • Life Assurance and Income Protection cover. • Performance related Bonus. • Fully equipped gym on site. • 39-hour week with flexible start & finish times  Candidates must hold a valid work permit/visa or EU citizenship to be considered. To Apply: If this job sounds ideal to you & you want to enquire in complete confidence or make an application, contact Darren Brown in Cpl Limerick on 087 405 3774 or email your details to darren.brown@cpl.ie.

511 days ago