Configurator Engineer contributing to tailoring solutions for banking and insurance AI. Collaborating with teams to optimize configurations and validate solutions for business requirements.
MA
Onsite R&D Engineer, Medical Devices
Posted 2 weeks ago
About the role
- 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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