Research and Development Engineer – Kildare

Full time Sparktel in Pharmaceutical Email Job
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Job Description

Our client is an established Medical Devices company based in Co. Kildare. Valued at in excess of €150m and with offices in Ireland and across Europe, the organisation is experiencing massive year on year growth. Due to this ongoing expansion and with the introduction of new products, we are seeking to hire a Research and Development Engineer. The key purpose of the R&D engineer is to work across the business to create innovate design solutions for the purpose of product improvement as well as new market opportunities. Full training will be provided, and you will join a team of dedicated and talented professionals.

Key Responsibilities:

  • Research and development of new technologies in coordination with other technical departments
  • Design medical devices using SolidWorks and carry out computational analysis, if required
  • Prototyping using 3D printing software
  • Carrying out verification of designs using a variety of experimental rigs and techniques
  • Analyse prototype performance and provide key input for each iteration
  • Product development of existing technologies and devices.
  • Complete design transfers, including technical support of the product being transferred. Define and draft the Process Validation Requirements (including IOQ/PQ/PPQ) for the transferred product.
  • Calibration of laboratory equipment
  • Aid in the timely completion of reports.
  • Understand and review validation documentation, change requests, design documents and technical drawings
  • Support of internal and external audits and regulatory programmes
  • Submission of regulatory changes to notified bodies and competent authorities.

Skills & Experience:

  • Third level degree in Engineering, Science or relevant discipline
  • Experience with SolidWorks required, with knowledge of CFD or FEA desirable.
  • Some laboratory experience would be preferred, such as writing test plans and reports and carrying out laboratory testing.
  • Good clinical & design principles required.
  • Good engineering and problem-solving skills a must.
  • Familiarity with international standards and regulations related to medical device development a plus.
  • Some knowledge of global medical device regulatory requirements, including MDD, MDR, FDA and C-FDA an advantage.
  • Understanding of engineering validation principles would be beneficial.
  • Capability of having a strategic as well as practical view on product development.
  • Capability to evaluate the customer demands and use that knowledge to prioritize device development.
  • Team player who can work effectively and proactively on cross-functional teams.
  • Competence to manage multiple projects at once and be results oriented
  • Good communication and influencing skills, with excellent written English
  • Must be eligible to visit USA, China and other areas for business related travel.
  • Good communication and influencing skills, with excellent written English
  • Sense of humour!