Job Description
Job Title: R&D Engineer – EU Medical Device Regulation (EU MDR)Job Description
This role focuses on leading research and development activities for medical devices intended for the EU market, with a strong emphasis on compliance with the EU Medical Device Regulation (EU MDR 2017/745). You will drive design, development, documentation, and regulatory strategy to ensure products meet both technical performance requirements and global regulatory obligations. Working as part of an R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams to deliver safe, effective, and compliant medical devices throughout the product lifecycle.
Responsibilities
+ Lead and support remediation design activities for medical devices in accordance with EU MDR 2017/745 and applicable international standards.
+ Conduct engineering studies, testing, and technical evaluations to ensure that design controls fully align with re...
This role focuses on leading research and development activities for medical devices intended for the EU market, with a strong emphasis on compliance with the EU Medical Device Regulation (EU MDR 2017/745). You will drive design, development, documentation, and regulatory strategy to ensure products meet both technical performance requirements and global regulatory obligations. Working as part of an R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams to deliver safe, effective, and compliant medical devices throughout the product lifecycle.
Responsibilities
+ Lead and support remediation design activities for medical devices in accordance with EU MDR 2017/745 and applicable international standards.
+ Conduct engineering studies, testing, and technical evaluations to ensure that design controls fully align with re...
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