R&D Engineer developing interventional medical devices to enhance patient safety and outcomes. Collaborating with cross-functional teams and ensuring compliance with regulatory frameworks.
Responsibilities
Contribute to customer-specific product development projects from concept freeze through detailed design and transfer to manufacturing.
Work across many areas of interventional devices, including access devices, advanced diagnostic and therapeutic catheters, and complex delivery systems, applying state-of-the-art technology.
Collaborate in cross-functional and international teams including program managers, design and process engineers, prototyping specialists, and RA/QA representatives—as well as with external business partners and customers.
Develop and build prototypes—both at the conceptual drafting stage and hands-on—aligned with safety, usability, and clinical performance requirements.
Develop test methods for design verification and simulated-use validation, define manufacturing processes, and document all work in our paperless PLM environment.
Ensure full and compliant documentation according to regulatory frameworks, standards, and industry best practices under our design control policies.
Requirements
Bachelor’s degree in a scientific or engineering discipline with a focus on Mechanical, Plastics, or Biomedical Engineering; an advanced degree is preferred.
Minimum of 3 years of experience in the interventional device industry.
Strong technical expertise in medical devices, applied materials, functional product design, design-for-manufacturability, and prototyping.
Excellent communication skills in English, both written and spoken.
Familiarity with Good Documentation Practice, Design Control, and relevant standards such as ISO 13485 and FDA requirements.
Willingness to travel occasionally to customers or clinical study locations worldwide.
Benefits
Curious? Apply now! We are interested in finding the best candidates, and they may come from a nontraditional background. So please don’t hesitate to apply, even if you aren’t an exact fit.
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