Biogen is a mid-sized biotechnology company dedicated to delivering life-changing medicines. They are looking for a Field Clinical Engineer to support the clinical use and deployment of Class III medical devices, providing technical support, education to healthcare professionals, and collecting insights for product development.
Responsibilities:
- Provide on-site support during implantation and follow-up procedures involving Class III medical devices. Troubleshoot technical issues during procedures and provide immediate, clinically sound recommendations
- Act as the subject matter expert (SME) on device function and clinical applications
- Educate physicians, nurses, and allied health professionals on device functionality, therapy benefits, and procedural workflows. Conduct in-service trainings, workshops, and ongoing clinical education for new and existing users
- Support collection of clinical data and user feedback to support regulatory submissions, product development, and continuous improvement efforts. Document field interactions in compliance with quality and regulatory standards
- Work closely with R&D, Regulatory, Safety, and Commercial teams to relay device deficiencies, clinical insights and support product refinements. Assist with investigational device trials, product evaluations, and site initiation visits (as applicable)
- Ensure all activities are performed in accordance with company policies, local regulations, and international standards (e.g., FDA, ISO 13485, MDR)
Requirements:
- Bachelor's degree in Biomedical Engineering, Nursing, Life Sciences, or related field and a minimum of 7 years of experience in a clinical or field support role for implantable medical devices
- Demonstrated experience providing field support for intrathecal device during clinical procedures
- Experience working in compliance with clinical trial regulations, SOPs, and study protocols
- Advanced degree (MS, PhD) or clinical credentials