Job Description
Our client, an innovative Medtech company based in Ireland, are now recruiting for Lead Sustaining R&D Engineer who will lead sustaining design support of commercial products in many varied projects that ensure safety, compliance and manufacturing continuity of this new product portfolio
The successful candidate will lead a number of R&D project teams, cycle, interacting with all relevant functional groups and presenting progress to management team.
Additionally, this hire will provide technical guidance to a team of R&D Engineers in the post commercialisation phase of the product lifecycle.
Responsibilities Lead Sustaining R&D Engineer:
Coordinate interrogation of reports, operational, test, and research data to enable design intent to be maintained on commercialised products whilst also helping provide post launch support by being a source of key product and clinical knowledge.
Lead groups in investigation of device performance and anatomy interaction, seeking opportunity for device improvement to optimise outcomes. Interfaces with vendors and physicians where projects require.
Leads a cross functional team to perform troubleshooting on products/process problems as related to design, material or process.
Maintain product performance through Quality Investigations and ensuring rigorous support for design changes.
Requirements for Lead Sustaining R&D Engineer:
Honours Bachelor's degree in Science, Engineering or equivalent Degree is required. MSc or PhD is desirable.
7+ years’ experience in a similar / relevant device design & development role (including design with SolidWorks, prototyping, and testing) is desired.
Proven leadership experience, including leading a team of R&D Engineers to project plan and delivering projects through key milestone phases and associated activities.
Proven experience of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements.
Proven experience in leading terms performing FMEAs, verifications and validations for medical devices products and processes.
Proven troubleshooting experience of products/process problems as related to design, material or process.
Please contact Larry on +353 1 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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