Sr R&D Engineer
An international medical device company is seeking to recruit a Senior R&D Engineer II to their office in Ireland. Known for their work in developing medical technologies, services, and solutions, the organisation prides itself on over 60 years of experience. This is the perfect opportunity to provide expertise and bolster a career in the Engineering field.
- Act as point person for technical questions from the field on commercial product.
- Liaise with quality and identify and complete post-market R&D work committed to during PDP phase.
- Engage with commercial manufacturing sites to understand planned change initiatives that will require R&D support, and often have regulatory implications.
- Negotiate with manufacturing sites regarding scope of work and timelines as necessary.
- Evaluate the workload associated with R&D approval of changes and develop a strategy to resource change approval such that impact to R&D resources is minimised.
- Act as subject matter expert in the evaluation and resolution of non-conforming material reports.
- Act as subject matter expert in the evaluation and resolution of issues resulting in the completion of product impact assessments.
- Support or identify a qualified Engineer to support ROW regulatory filings, following Western Europe and US approval. Complete R&D activities necessary for periodic regulatory recertification (compliance to ISO standards).
Skills and Requirements:
- Bachelor's degree in engineering (Mechanical, Materials, or Biomedical) - Advanced technical degree is preferred.
- Minimum of 4 years of experience in medical device product development; 2 years with a MS degree.
- Experience with complex catheter-based delivery systems.
- Experience with implantable cardiovascular devices.
- Experience in commercial manufacturing and production of medical devices.
- Prior experience in medical device quality systems is required and depth knowledge of the Medtronic Quality System is preferred.
- Experience in engaging with regulatory bodies, through regulatory filings and audit/inspection support.
- Comprehensive knowledge of ISO and FDA requirements and guidance.
- Proficiency in SolidWorks.
- Knowledge of statistical analysis software and applications.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact James Wilson at +44 203 762 2703 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.