Biogen is a mid-sized biotechnology company committed to delivering life-changing medicines. They are seeking a Field Clinical Engineer to support the clinical use and deployment of Class III medical devices, providing technical support and education to healthcare professionals while collecting field 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