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Senior Research & Development Engineer

ID
13788
Location
Limerick
Role Type
Permanent
Contact
Johanne Kennedy
Email
choices@hero.ie
Phone
+353 86 440 3725
LinkedIn
click here
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Job Title: Senior Research & Development Engineer 

Overview: 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: 
  • 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.
  • 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 & Development team/s including technical and project management leadership responsibly, if required.
  • Lead technical development of projects. Lead 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. o 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 direct reports, if required.
  • Regular communication to cross-functional teams, senior management and business unit leaders.
  • Project status communications and reporting.
  • Ensure effective reporting to the R&D Manager or R&D Team leader.
  • 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.
  • Ensure the Code of Conduct is considered in all business matters carried out on Company’s behalf.

Qualifications:

  • Third level degree in Mechanical, Biomedical, Science, Design or similar discipline, Masters or Ph.D. level preferred but not essential.
  • 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 manufacturing design and process understanding.
  • Good working knowledge of Solidworks and/or Pro Engineer CAD. Good presentation skills (working knowledge of MS PowerPoint).
  • Strong technical writer.
  • Attention to detail and Quality focus.
  • Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820).
  • Team Player with ability to develop strong working relationships.
  • Strong communication and inter-personal skills.
  • Good problem solving skills.
  • Highly motivated individual, self-starter with a passion for excellence.
  • Must be able to work in a fast paced environment.
  • 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.
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