Senior Research and Development Engineer - Vernon, United States - FusionWorks
Description
One of the most innovative and rapidly growing medical device companies in the Baden-Württemberg region is seeking a Senior R&D Engineer. Please note that prior experience in the medical device industry is required for this role.
Responsibilities:
- Lead and participate in the design, development, and testing of new medical devices, ensuring compliance with regulatory standards and industry best practices.
- Drive innovation within the R&D team by staying up-to-date on emerging technologies, conducting feasibility studies, and proposing new approaches to product development.
- Oversee the prototyping process, including fabricating prototypes, conducting design verification and validation testing, and implementing design improvements based on test results.
- Maintain accurate and detailed documentation throughout the product development lifecycle, including design specifications, test protocols, and regulatory submissions, to ensure compliance with regulatory requirements (e.g., ISO 13485, FDA QSR, MDR).
- Provide technical guidance and mentorship to junior engineers, fostering a culture of learning and innovation within the R&D team.
Qualifications:
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field; Master's degree or PhD preferred.
- Minimum of 5 years of experience in medical device product development, with a proven track record of successfully bringing products from
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