Our client, a medical device company in Galway are currently looking to recruit a Post Market R&D Engineer for their site.
The commercial product R&D engineer will support post-commercial R&D activities for the aortic endovascular business. This engineering position requires solid technical and leadership skills to maintain the rigor and diligence necessary for commercial product support. The engineer will apply technical principles, theories, and new concepts to collaboratively solve difficult technical problems and assess impact of proposed changes on form, fit and function of designs. The engineer will work under the limited direction of the post market lead but will have significant latitude in determining methods of solving problems, design and construction of analysis associated with commercial product testing.
• Technical review and approval of change orders initiated by internal manufacturing sites.
• Review and approval of post market surveillance reports, and any subsequent updates for risk management documentation.
• Root cause analysis related to commercial issues, including technical support of non-conforming material reports and product impact assessments.
• Contributor or owner of corrective actions / preventative actions (CAPAs).
• Support of rest of world (ROW) regulatory filings and regulatory recertification.
• Point of contact for technical questions from sales, marketing and clinical organizations for specification and design questions.
• Identify and correct issues missed by PDP teams to ensure technical excellence and compliance of commercial products.
The post-market R&D engineer is responsible for support and execution of the following in collaboration with the R&D post market engineering team and lead. The commercial product engineer may be individually accountable for these actions.
• Act as point person for technical questions from the field on commercial product.
• Accountable for liaising with quality, to 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 minimized.
• 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).
- Bachelors degree required.
- Minimum of 2 years of experience, or advanced degree with 0 years of experience required.
- Degree in engineering (Mechanical, Materials, or Biomedical) – Advanced technical degree is preferred.
- Minimum of 2 years of experience in medical device product development.
- 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.
- 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.
- Excellent communications skills (written and verbal).
- Ability to work in a team.
- Self-starter and driver – able to execute effectively and work efficiently.
- Proficient in mechanical engineering fundamentals and uses of good engineering judgement.
Travel Expectations: About 10% of the time
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